ABSTRACT
Noninvasive ventilation interfaces are one of the main factors contributing to pressure injuries caused by medical devices. Prevention is still the best course of action when discussing noninvasive ventilation-induced pressure injuries. A systematic review was designed to summarize and analyse all published literature on strategies to prevent pressure injuries caused by masks in patients undergoing noninvasive ventilation. The protocol of the systematic review followed the PRISMA guideline. An extensive search from the beginning to May 16, 2023, using current articles in databases such as Web of Science (WOS), Scopus, PubMed, and Cochrane Library was conducted. Medical Subject Headings (MESH) were used as follows: "Pressure Injury," "Noninvasive Ventilation," "Prevention," and "Pressure Sore." Any language-published studies that met the inclusion criteria were included in this review. A risk of bias assessment was conducted using the Joanna Briggs Institute tool, including evaluation methodologies for all studies. Database searches yielded 2546 articles, which were reduced to 23 that met our criteria after reviewing full texts. A narrative synthesis was conducted. As a result, type of interface (14 studies), dressings (4 studies), adjustment of mask leakage (1 study), humidity (1 study), positioning (1 study), and design of personalized masks (2 studies) seem to be a practical approach to prevent pressure injuries caused by masks in patients undergoing noninvasive ventilation. The results of our study show the effectiveness of preventive methods in reducing the incidence of pressure injuries caused by masks. Given the significant occurrence of pressure injury related to noninvasive ventilation and the crucial role of prevention and treatment, it is imperative to conduct more rigorous studies to ascertain the efficacy of each strategy.
Subject(s)
Masks , Noninvasive Ventilation , Pressure Ulcer , Humans , Pressure Ulcer/prevention & control , Pressure Ulcer/etiology , Masks/adverse effects , Noninvasive Ventilation/adverse effects , Noninvasive Ventilation/methods , Noninvasive Ventilation/instrumentation , Female , Male , Aged , Middle Aged , Adult , Aged, 80 and overABSTRACT
IMPORTANCE: Patients presenting to the emergency department (ED) with hypoxemia often have mixed or uncertain causes of respiratory failure. The optimal treatment for such patients is unclear. Both high-flow nasal cannula (HFNC) and noninvasive ventilation (NIV) are used. OBJECTIVES: We sought to compare the effectiveness of initial treatment with HFNC versus NIV for acute hypoxemic respiratory failure. DESIGN SETTING AND PARTICIPANTS: We conducted a retrospective cohort study of patients with acute hypoxemic respiratory failure treated with HFNC or NIV within 24 hours of arrival to the University of Michigan adult ED from January 2018 to December 2022. We matched patients 1:1 using a propensity score for odds of receiving NIV. MAIN OUTCOMES AND MEASURES: The primary outcome was major adverse pulmonary events (28-d mortality, ventilator-free days, noninvasive respiratory support hours) calculated using a win ratio. RESULTS: A total of 1154 patients were included. Seven hundred twenty-six (62.9%) received HFNC and 428 (37.1%) received NIV. We propensity score matched 668 of 1154 (57.9%) patients. Patients on NIV versus HFNC had lower 28-day mortality (16.5% vs. 23.4%, p = 0.033) and required noninvasive treatment for fewer hours (median 7.5 vs. 13.5, p < 0.001), but had no difference in ventilator-free days (median [interquartile range]: 28 [26, 28] vs. 28 [10.5, 28], p = 0.199). Win ratio for composite major adverse pulmonary events favored NIV (1.38; 95% CI, 1.15-1.65; p < 0.001). CONCLUSIONS AND RELEVANCE: In this observational study of patients with acute hypoxemic respiratory failure, initial treatment with NIV compared with HFNC was associated with lower mortality and fewer composite major pulmonary adverse events calculated using a win ratio. These findings underscore the need for randomized controlled trials to further understand the impact of noninvasive respiratory support strategies.
Subject(s)
Cannula , Hypoxia , Noninvasive Ventilation , Propensity Score , Respiratory Insufficiency , Humans , Noninvasive Ventilation/methods , Noninvasive Ventilation/instrumentation , Noninvasive Ventilation/adverse effects , Retrospective Studies , Male , Female , Middle Aged , Hypoxia/therapy , Hypoxia/mortality , Aged , Respiratory Insufficiency/therapy , Respiratory Insufficiency/mortality , Oxygen Inhalation Therapy/methods , Oxygen Inhalation Therapy/instrumentation , Cohort Studies , Acute Disease , Emergency Service, Hospital/statistics & numerical data , Treatment OutcomeABSTRACT
BACKGROUND: Invasive mechanical ventilation contributes to bronchopulmonary dysplasia (BPD), the most common complication of prematurity and the leading respiratory cause of childhood morbidity. Non-invasive ventilation (NIV) may limit invasive ventilation exposure and can be either synchronized or non-synchronized (NS). Pooled data suggest synchronized forms may be superior. Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) delivers NIV synchronized to the neural signal for breathing, which is detected with a specialized catheter. The DIVA (Diaphragmatic Initiated Ventilatory Assist) trial aims to determine in infants born 240/7-276/7 weeks' gestation undergoing extubation whether NIV-NAVA compared to non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV) reduces the incidence of extubation failure within 5 days of extubation. METHODS: This is a prospective, unblinded, pragmatic, multicenter phase III randomized clinical trial. Inclusion criteria are preterm infants 24-276/7 weeks gestational age who were intubated within the first 7 days of life for at least 12 h and are undergoing extubation in the first 28 postnatal days. All sites will enter an initial run-in phase, where all infants are allocated to NIV-NAVA, and an independent technical committee assesses site performance. Subsequently, all enrolled infants are randomized to NIV-NAVA or NS-NIPPV at extubation. The primary outcome is extubation failure within 5 days of extubation, defined as any of the following: (1) rise in FiO2 at least 20% from pre-extubation for > 2 h, (2) pH ≤ 7.20 or pCO2 ≥ 70 mmHg; (3) > 1 apnea requiring positive pressure ventilation (PPV) or ≥ 6 apneas requiring stimulation within 6 h; (4) emergent intubation for cardiovascular instability or surgery. Our sample size of 478 provides 90% power to detect a 15% absolute reduction in the primary outcome. Enrolled infants will be followed for safety and secondary outcomes through 36 weeks' postmenstrual age, discharge, death, or transfer. DISCUSSION: The DIVA trial is the first large multicenter trial designed to assess the impact of NIV-NAVA on relevant clinical outcomes for preterm infants. The DIVA trial design incorporates input from clinical NAVA experts and includes innovative features, such as a run-in phase, to ensure consistent technical performance across sites. TRIAL REGISTRATION: www. CLINICALTRIALS: gov , trial identifier NCT05446272 , registered July 6, 2022.
Subject(s)
Interactive Ventilatory Support , Noninvasive Ventilation , Infant , Infant, Newborn , Humans , Intermittent Positive-Pressure Ventilation/adverse effects , Infant, Extremely Premature , Interactive Ventilatory Support/adverse effects , Interactive Ventilatory Support/methods , Airway Extubation/adverse effects , Prospective Studies , Noninvasive Ventilation/adverse effects , Noninvasive Ventilation/methods , Randomized Controlled Trials as Topic , Multicenter Studies as Topic , Clinical Trials, Phase III as TopicABSTRACT
BACKGROUND: Nasal mask (NM) and oronasal masks (OM) can be used to provide noninvasive ventilation (NIV). Recent studies suggested that OM is the most used interface and that there is no difference in efficacy or in tolerance between OM and NM for chronic use. However, studies focusing on video laryngoscopy underlined the impact of OM in residual upper airway obstruction (UAO) under NIV. We sought to assess the real-life practice of switching from OM to NM when UAO events persist despite high EPAP levels. METHODS: In an open-label single center prospective cohort study, data from files and full night polysomnography on NM and OM were collected for patients wearing OM and presenting an UAO index ≥15/h despite an EPAP level ≥ 10 cmH20. RESULTS: Forty-four patients were included in the study. In 31 patients (74 %), switching to a NM reduced UAOi to ≥10/h. Interestingly, 92 % of these patients still had NM at 3 to 12 months of follow-up. Switching to a NM was also associated with a trend in paCO2 reduction and significant improvements in Epworth, sleep quality and NIV compliance. Successful interface switching was significantly associated with female gender, and a trend was observed in non-smokers. CONCLUSION: As for CPAP, switching to a NM improved NIV efficacy in a selected group of patients presenting residual UAO events despite high EPAP levels. Additionally, this switch has an impact on compliance and subjective sleepiness. Thus, in patients with persisting UAO on OM, switching to a NM could be a first-line intervention before considering further investigation such as polygraphy or video laryngoscopy. We also derive an algorithm for mask allocation and adaptation in acute and chronic NIV use.
Subject(s)
Airway Obstruction , Masks , Noninvasive Ventilation , Polysomnography , Humans , Male , Female , Noninvasive Ventilation/methods , Noninvasive Ventilation/instrumentation , Noninvasive Ventilation/adverse effects , Prospective Studies , Middle Aged , Masks/adverse effects , Aged , Airway Obstruction/therapy , Airway Obstruction/etiology , Positive-Pressure Respiration/methods , Positive-Pressure Respiration/instrumentation , Positive-Pressure Respiration/adverse effects , Continuous Positive Airway Pressure/methods , Continuous Positive Airway Pressure/adverse effects , Continuous Positive Airway Pressure/instrumentation , Sleep Apnea, Obstructive/therapyABSTRACT
BACKGROUND: High-flow nasal cannula (HFNC) and conventional oxygen therapy (COT) are important respiratory support strategies for acute hypoxemic respiratory failure (AHRF) in coronavirus disease 2019 (COVID-19) patients. However, the results are conflicting for the risk of intubation with HFNC as compared to COT. OBJECTIVES: We systematically synthesized the outcomes of HFNC relative to COT in COVID-19 patients with AHRF and evaluated these outcomes in relevant subpopulations. DESIGN: This study was designed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. DATA SOURCES AND METHODS: We searched PubMed, EMBASE, Web of Science, Scopus, ClinicalTrials.gov, medRxiv, BioRxiv, and the Cochrane Central Register of Controlled Trials for randomized controlled trials and observational studies that compared the efficacy of HFNC with COT in patients with COVID-19-related AHRF. Primary outcomes were intubation rate and mortality rate. Secondary outcomes were the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), respiratory rate, hospital length of stay, intensive care unit (ICU) length of stay, and days free from invasive mechanical ventilation. RESULTS: In total, 20 studies with 5732 patients were included. We found a decreased risk of requiring intubation in HFNC compared to COT [odds ratio (OR) = 0.61, 95% confidence interval (CI): 0.46-0.82, p = 0.0009, I2 = 75%]. Similarly, we found HFNC was associated with lower risk of intubation rate compared to COT in the subgroup of patients with baseline PaO2/FiO2 < 200 mmHg (OR = 0.69, 95% CI: 0.55-0.86, p = 0.0007, I2 = 45%), and who were in ICU settings at enrollment (OR = 0.57, 95% CI: 0.38-0.85, p = 0.005, I2 = 80%). HFNC was associated with an improvement of PaO2/FiO2 and respiratory rate compared to COT. The use of HFNC compared to COT did not reduce the mortality rate, days free from invasive mechanical ventilation, hospital length of stay, or ICU length of stay. CONCLUSION: Compared to COT, HFNC may decrease the need for tracheal intubation in patients with COVID-19-related AHRF, particularly among patients with baseline PaO2/FiO2 < 200 mmHg and those in ICU settings. TRIAL REGISTRATION: This systematic review and meta-analysis protocol was prospectively registered with PROSPERO (no. CRD42022339072).
Subject(s)
COVID-19 , Noninvasive Ventilation , Respiratory Insufficiency , Humans , Cannula , COVID-19/therapy , Noninvasive Ventilation/adverse effects , Noninvasive Ventilation/methods , Oxygen , Oxygen Inhalation Therapy/adverse effects , Respiratory Insufficiency/therapy , Respiratory Insufficiency/etiologyABSTRACT
OBJECTIVE: To assess the effect of different noninvasive ventilation interfaces on preventing the facial pressure injury. METHODS: This network meta-analysis was conducted following the PRISMA reporting guidelines. Seven electronic databases were systematically searched for randomised controlled trials about the comparative effectiveness of different interfaces in preventing facial pressure injury with noninvasive ventilation in adults and newborns from inception to June 2023. The acronym of PICOS was used and the keywords as well as inclusion/exclusion criteria were determined. Study selection and data extraction were performed by two independent reviewers. The Cochrane risk of bias assessment tool was used to assess the methodological quality. RESULTS: A total of 78 randomised controlled trials involving 7,291 patients were included. The results of network meta-analysis showed that the effectiveness of the eight noninvasive ventilation interfaces on the prevention of facial pressure injury was in the order of: nasal cannula > full-face mask > rotation of nasal mask with nasal prongs > helmet > nasal mask > oronasal mask > nasal prongs > face mask. The use of full-face mask in adults and nasal cannula in newborns had the best effect on preventing the incidence of facial pressure injury. CONCLUSIONS: The use of full-face mask in adults and nasal cannula in newborns had the most clinical advantage in preventing the incidence of facial pressure injury and were worthy promoting in clinical practice. IMPLICATIONS FOR CLINICAL PRACTICE: This study provides a certain theoretical basis for the selection of appropriate interface for patients with noninvasive ventilation. Clinical practitioners should choose the appropriate interfaces based on the patient's specific condition to reduce the incidence of facial pressure injury, enhance patient comfort, and improve the effectiveness of respiratory therapy.
Subject(s)
Noninvasive Ventilation , Pressure Ulcer , Adult , Humans , Infant, Newborn , Noninvasive Ventilation/adverse effects , Noninvasive Ventilation/methods , Pressure Ulcer/prevention & control , Pressure Ulcer/etiology , Network Meta-Analysis , Masks/adverse effects , Incidence , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: High-flow nasal cannula (HFNC) oxygen is an alternative to conventional oxygen in acute hypoxaemic respiratory failure. Some patients require intubation, with a risk of delay; thus, early predictors may identify those requiring earlier intubation. The "ROX" index (ratio of pulse oximetry/fraction of inspired oxygen to respiratory rate) predicts intubation in patients with pneumonia treated with HFNC therapy, but this index has not been validated in non-pneumonia causes of acute hypoxaemic respiratory failure. AIM/OBJECTIVE: The aim of this study was to identify factors associated with intubation in a heterogeneous group of patients with acute hypoxaemic respiratory failure treated with HFNC oxygen. METHODS: This prospective observational study was undertaken in an Australian tertiary intensive care unit and included patients over 18 y of age with acute hypoxaemic respiratory failure who were treated with oxygen via HFNC. Vital signs and arterial blood gases were recorded prospectively at baseline and regular prespecified intervals for 48 h after HFNC initiation. Multivariate logistic regression was used to identify the factors associated with intubation. RESULTS: Forty-three patients were included (N = 43). The multivariate factors associated with intubation were admission Sequential Organ Failure Assessment score (odds ratio [OR]: 1.94 [95% confidence interval {CI}: 1.06-3.57]; p = 0.032) and Pneumonia Severity Index (OR: 0.95 [95% CI: 0.90-0.99]; p = 0.034). The ROX index was not independently associated with intubation when adjusted for Sequential Organ Failure Assessment score (OR: 0.71 [95% CI: 0.47-1.06]; p = 0.09). There was no difference in mortality between patients intubated early (<24 h) compared to those intubated late. CONCLUSIONS: Intubation was associated with admission Sequential Organ Failure Assessment score and Pneumonia Severity Index. The ROX index was not associated with intubation when adjusted for admission Sequential Organ Failure Assessment score. Outcomes were similar irrespective of whether patients were intubated late rather than early.
Subject(s)
Noninvasive Ventilation , Pneumonia , Respiratory Insufficiency , Humans , Adult , Middle Aged , Cannula/adverse effects , Prospective Studies , Intubation, Intratracheal/adverse effects , Noninvasive Ventilation/adverse effects , Australia , Oxygen Inhalation Therapy/adverse effects , Oxygen , Respiratory Insufficiency/therapy , Pneumonia/therapy , Retrospective StudiesABSTRACT
INTRODUCTION: Home noninvasive ventilation (HNIV) has expanded globally, with a greater evidence base for its use. HNIV improves multiple patient related outcomes in patients with chronic hypercapnic respiratory failure. Obesity hypoventilation syndrome (OHS) is rapidly taking over as the primary indication for HNIV and COPD patients who overlap with obstructive sleep apnea hypoventilation syndromes (OSAHS) and are increasingly recognized but add to the complexity of HNIV prescribing. Optimal settings vary for differing diseases, with higher inspiratory pressures often required in those with OHS and COPD, yet which settings translate into greatest patient benefit remains unknown. AREAS COVERED: We cover the evidence base underpinning the common indications for HNIV in COPD, OHS, neuromuscular disease (NMD), and chest wall disease (CWD) and highlight common HNIV modes used. EXPERT OPINION: Active screening for nocturnal hypoventilation in OHS and COPD may be important to guide earlier ventilation. Further research on which HNIV modalities best improve patient related outcomes and the right time for initiation in different patient phenotypes is rapidly needed. Worldwide, clinical research trials should aim to bridge the gap by reporting on patient-related outcomes and cost effectiveness in real-world populations to best understand the true benefit of HNIV amongst heterogenous patient populations.
Subject(s)
Noninvasive Ventilation , Obesity Hypoventilation Syndrome , Pulmonary Disease, Chronic Obstructive , Humans , Noninvasive Ventilation/adverse effects , Hypoventilation/diagnosis , Hypoventilation/therapy , Respiration, Artificial , Obesity Hypoventilation Syndrome/therapy , Pulmonary Disease, Chronic Obstructive/therapy , HypercapniaABSTRACT
BACKGROUND: Health problems in neonates with gestational age (GA) ≥ 32 weeks remain a major medical concern. Respiratory distress (RD) is one of the common reasons for admission of neonates with GA ≥ 32 weeks. Noninvasive ventilation (NIV) represents a crucial approach to treat RD, and currently, the most used NIV modes in neonatal intensive care unit include high-flow nasal cannula (HFNC), continuous positive airway pressure (CPAP), and nasal intermittent positive pressure ventilation. Although extensive evidence supports the use of NIPPV in neonates with a GA < 32 weeks, limited data exist regarding its effectiveness in neonates with GA ≥ 32 weeks. Therefore, the aim of this study is to compare the clinical efficacy of HFNC, CPAP, and NIPPV as primary NIV in neonates with GA ≥ 32 weeks who experience RD. METHODS: This trial is designed as an assessor-blinded, three-arm, multi-center, parallel, randomized controlled trial, conducted in neonates ≥ 32 weeks' GA requiring primary NIV in the first 24 h of life. The neonates will be randomly assigned to one of three groups: HFNC, CPAP or NIPPV group. The effectiveness, safety and comfort of NIV will be evaluated. The primary outcome is the occurrence of treatment failure within 72 h after enrollment. Secondary outcomes include death before discharge, surfactant treatment within 72 h after randomization, duration of both noninvasive and invasive mechanical ventilation, duration of oxygen therapy, bronchopulmonary dysplasia, time to achieve full enteral nutrition, necrotizing enterocolitis, duration of admission, cost of admission, air leak syndrome, nasal trauma, and comfort score. DISCUSSION: Currently, there is a paucity of data regarding the utilization of NIPPV in neonates with GA ≥ 32 weeks. This study will provide clinical evidence for the development of respiratory treatment strategies in neonates at GA ≥ 32 weeks with RD, with the aim of minimizing the incidence of tracheal intubation and reducing the complications associated with NIV. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2300069192. Registered on March 9, 2023, https://www.chictr.org.cn/showproj.html?proj=171491 .
Subject(s)
Noninvasive Ventilation , Respiratory Distress Syndrome, Newborn , Infant, Newborn , Humans , Infant , Intermittent Positive-Pressure Ventilation/adverse effects , Intermittent Positive-Pressure Ventilation/methods , Continuous Positive Airway Pressure/adverse effects , Continuous Positive Airway Pressure/methods , Gestational Age , Infant, Premature , Cannula , Respiratory Distress Syndrome, Newborn/diagnosis , Respiratory Distress Syndrome, Newborn/therapy , Noninvasive Ventilation/adverse effects , Dyspnea , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
Introduction: Determinants of long-term mortality following acute hypercapnic respiratory failure have been extensively studied in patients with chronic obstructive pulmonary disease. However, respiratory failure due to obesity has not been studied to the same extent. This retrospective survey aims to identify whether admission pH is associated with long-term mortality in patients requiring acute noninvasive ventilation (NIV) for obesity-related respiratory failure (ORRF). Methods: Records from April 2013 to March 2020 were accessed from a NIV quality database at an acute teaching hospital. Adults with hypercapnic ORRF requiring acute NIV were included. pH data were grouped by threshold (pH≤ and >7.25) and correlated with time from presentation to death; multivariable analysis was performed using Cox proportional hazards. Results: A total of 277 acute NIV episodes were included. Two-year mortality was similar for patients in both pH categories. Univariable analysis identified pH ≤ 7.25 to increase risk of two-year mortality by 43%. However, multivariable analysis identified that pH was not a significant determinant of long-term mortality, although male sex, older age, and higher admission pCO2 increased the risk of death at two years by 76%, 3% per year of age, and 16% per 1 kPa of pCO2 increase, respectively. Conclusion: Severity of hypercapnia on admission, male sex, and older age are associated with worse two-year mortality in patients requiring acute NIV for ORRF. There is scope for further analyses including investigating the role of domiciliary NIV in ORRF patients.
Subject(s)
Noninvasive Ventilation , Pulmonary Disease, Chronic Obstructive , Respiratory Insufficiency , Adult , Humans , Male , Noninvasive Ventilation/adverse effects , Retrospective Studies , Respiration, Artificial/adverse effects , Respiratory Insufficiency/therapy , Respiratory Insufficiency/complications , Pulmonary Disease, Chronic Obstructive/complications , Pulmonary Disease, Chronic Obstructive/therapy , Obesity/complications , Obesity/therapyABSTRACT
Chronic obstructive pulmonary disease can lead to acute hypercapnic respiratory failure (AHRF), often treated using noninvasive ventilation (NIV). Emerging research suggests the potential utility of high flow nasal cannula (HFNC) for AHRF. This systematic review and meta-analysis aimed to determine the effect of HFNC versus NIV on AHRF management. A search of electronic databases (CINAHL, MEDLINE, and Academic Search Complete), web sources, and trial registries was last conducted on 9 February 2023. Quality and risk of bias assessments were conducted. Meta-analyses were used to synthesise data. Seven randomised controlled trials were included. No statistically significant differences between HFNC and NIV were found within the following outcomes of interest: (i) correction of pCO2: standardised mean difference (SMD) = -0.16, 95% confidence interval (CI) (-0.34 to 0.02), p = 0.08; (ii) correction of pH: SMD = -0.05, 95% CI (-0.25 to 0.14), p = 0.59; (iii) correction of pO2: SMD = -0.15, 95% CI (-0.40 to 0.09), p = 0.22; (iv) intubation rates: risk ratio (RR) = 0.87, 95% CI (0.41 to 1.82), p = 0.71; (v) mortality rates: RR = 0.85, 95% CI (0.47 to 1.56), p = 0.61; and (vi) treatment switch: RR = 1.30, 95% CI (0.43 to 3.94), p = 0.64. More controlled trials with large sample sizes are required to investigate the management of AHRF of various aetiologies. HFNC may be used as a final exhaustive measure for COPD-related AHRF where NIV is not tolerated, and when it is not clinically indicated to extend to endotracheal intubation.
Subject(s)
Noninvasive Ventilation , Pulmonary Disease, Chronic Obstructive , Respiratory Insufficiency , Humans , Noninvasive Ventilation/adverse effects , Cannula , Respiratory Insufficiency/therapy , Intubation, Intratracheal , Pulmonary Disease, Chronic Obstructive/complications , Pulmonary Disease, Chronic Obstructive/therapy , Oxygen Inhalation TherapyABSTRACT
BACKGROUND AND OBJECTIVES: An increasing number of children with diverse medical conditions are using long-term noninvasive ventilation (NIV). This study examined the impact of demographic, clinical, and technology-related factors on long-term NIV adverse events in a large cohort of children using long-term NIV. METHODS: This was a multicenter retrospective review of all children who initiated long-term NIV in the province of Alberta, Canada, from January 2005 to September 2014, and followed until December 2015. Inclusion criteria were children who had used NIV for 3 months or more and had at least one follow-up visit with the NIV programs. RESULTS: We identified 507 children who initiated NIV at a median age of 7.5 (interquartile range: 8.6) years and 93% of them reported at least one NIV-related adverse event during the initial follow-up visit. Skin injury (20%) and unintentional air leaks (19%) were reported more frequently at the initial visit. Gastrointestinal symptoms, midface hypoplasia, increased drooling, aspiration and pneumothorax were rarely reported (<5%). Younger age and underlying conditions such as Down syndrome, achondroplasia, and Duchenne muscular dystrophy were early predictors of unintentional air leak. Younger age also predicted child sleep disruption in the short term and ongoing parental sleep disruption. Obesity was a risk factor for persistent nasal symptoms. Mask type was not a significant predictor for NIV-related short- or long-term complications. CONCLUSIONS: This study demonstrates that NIV-related complications are frequent. Appropriate mask-fitting and headgear adaptation, and a proactive approach to early detection may help to reduce adverse events.
Subject(s)
Noninvasive Ventilation , Humans , Child , Noninvasive Ventilation/adverse effects , Continuous Positive Airway Pressure , Sleep , Retrospective Studies , ObesityABSTRACT
BACKGROUND: The ETAPES program is a national telemedicine experiment conducted in France between 2018 and 2023 to investigate whether home non-invasive ventilation (NIV) telemonitoring improves healthcare pathways in patients with chronic respiratory failure (CRF) and impacts healthcare organization. The program provides a combination of therapeutic education and NIV telemonitoring with data processed by an algorithm generating alerts. The TELVENT study objective was to analyze the evolution of ventilation quality in patients included in the ETAPES program. METHODS: Multicentric cohort study on patients undergoing long-term NIV included in the ETAPES program between September 2018 and December 2020 and who did not refuse the use of their data for this research. Data were obtained from homecare provider databases. The primary endpoint was to attain successful NIV treatment, which was determined by a combination of daily NIV usage for > 4 h per day, low leaks, and a low apnea-hypopnea index (AHI) identified by the NIV device. Respiratory disability was assessed using the DIRECT questionnaire. RESULTS: 329 patients were included in the study of which 145 had COPD and 83 had started NIV and ETAPES within one-month delay. Approximately 25% of patients did not achieve the criteria for successful NIV at ETAPES entry. The proportion of patients with successful NIV treatment increased to 86.8% at six months (p = 0.003, Cochran-Armitage trend test) regardless of NIV history and continued to increase at 12 months in newly equipped NIV patients (93.8%, at month 12, p = 0.0026 for trend test). Over time, a significant increase in NIV use and compliance was observed, while AHI significantly decreased in the overall population. No significant decrease was observed for non-intentional leaks. Approximately 4.9 alerts were generated per patient per 6 months. Their number and type (low NIV use, high AHI or leaks) differed among patients based on their NIV history. Respiratory disability score decreased over time compared with baseline. CONCLUSION: The TELVENT study highlights the importance of remote NIV monitoring to rapidly identify patients with unsuccessful ventilation. The combination of remote monitoring and therapeutic education may improve the quality of home NIV, especially in the first months of treatment.
Subject(s)
Acidosis, Respiratory , Noninvasive Ventilation , Respiratory Insufficiency , Humans , Noninvasive Ventilation/adverse effects , Cohort Studies , Respiratory Insufficiency/therapy , Respiratory Insufficiency/etiology , Lung , Acidosis, Respiratory/etiologyABSTRACT
BACKGROUND: Nalmefene is an opioid system modulator with antagonist activity at the µ and δ receptors and partial agonist activity at the κ receptor. Previous studies have suggested that nalmefene could improve respiratory function in patients with chronic obstructive pulmonary disease (COPD). However, there is no comprehensive systematic review published regarding the clinical efficacy of nalmefene. METHODS: We explored the following electronic bibliographic databases: EMBASE, Web of Science, PubMed, Wanfang, and Chinese national knowledge infrastructure. To collect data from randomized controlled trials on the therapy of COPD coupled with type II respiratory failure and nalmefene + noninvasive ventilator treatment. The retrieved articles were screened to determine the final inclusion criteria and to extract relevant data, such as the clinical efficacy rate, pulmonary function, blood gas analysis, and adverse reactions. In our study, we used relative risk and weighted mean deviation, as well as a 95% confidence interval for describing nalmefene effectiveness and safety while treating COPD with type II respiratory failure. RESULTS: The outcomes of the meta-analysis demonstrated that the clinical efficacy rate of the nalmefene + noninvasive ventilation group was higher than that of the naloxone + noninvasive ventilation and noninvasive ventilation groups. Moreover, the improvement indices of pH value, partial pressure and saturation of blood oxygen, partial pressure of carbon dioxide, and pulmonary function of the nalmefene + noninvasive ventilation group were better than those of the noninvasive ventilation group, and there was no increase in the occurrence of adverse drug reactions. CONCLUSION: Nalmefene combined with noninvasive ventilation can significantly improve the blood gas index and lung function in patients with COPD combined with type II respiratory failure.
Subject(s)
Noninvasive Ventilation , Pulmonary Disease, Chronic Obstructive , Respiratory Insufficiency , Humans , Noninvasive Ventilation/adverse effects , Positive-Pressure Respiration , Pulmonary Disease, Chronic Obstructive/complications , Pulmonary Disease, Chronic Obstructive/drug therapy , Respiratory Insufficiency/etiologyABSTRACT
BACKGROUND: The management of oral health during severe symptoms of Covid-19 is still a challenge, especially in intensive care units under invasive/noninvasive ventilation in hospital. Understanding the cause-and-effect relationships may allow for individual adjustment of oral care recommendations during Covid-19 disease. The study's objective was to assess Covid-19 patients' oral health status under hospital treatment due to pulmonary adverse Covid-19 outcomes. MATERIAL AND METHODS: Covid-19 patients (mean age 74.4 ± 15.4; n = 120, male n = 50/female n = 70) were admitted to hospital in the acute phase of Covid-19 between January and March 2022 who required oxygen therapy due to pneumonia, rapid respiratory failure, low saturation. Blood and radiological tests were taken according to National Health Fund guidelines. The condition of teeth (Decayed, Missing, Filled teeth as DMFT index), dental hygiene (Plaque Control Record as PCR index), periodontal status (probing depth PD, clinical attachment CAL, bleeding on probing BOP) and oral mucosa (BRUSHED and Beck scores) were examined. RESULTS: Charateristics of the teeth (dental caries 35.2%, DMFT Median 22), plaque retention (83.4%), advanced periodontitis (48.3%), xerostomia (74.2%), oral mucosa inflammation (80.8%), angular cheilitis (53.3%), hemorrhagic (21.7%) showed a high incidence of harmful oral conditions. BRUSHED model and Beck score indicated moderate oral dysfunction and need for oral care every 8 h. Spearman's analysis revealed a significant positive correlation between pneumonia and neutrophile, interleukin-6 IL-6, C-reactive protein CRP (p = 0.01, p < 0.001, p < 0.001), negative to lymphocyte count (p < 0.001). Multiple and logistic regressions selected the following risk predictors for pneumonia as IL-6, CRP, obesity and for severe COVID-19 symptoms D-dimer level and a lack of targeted vaccination (p < 0.001). Among oral predictors, the PCR index and Beck score were significant for both outcomes (respectively p < 0.001, p < 0.012). Patients who received oxygen therapy with face masks had more often angular heilitis and debris (p = 0.025, p = 0.035). CONCLUSIONS: COVID-19 hospitalised patients with severe symptoms crossing with poor oral health-related conditions. This may exacerbate a response for COVID infection, and play a role in cytokine storm. For Covid-19 management, to inhibit extraoral/intraoral complications, it is recommended to adjust oral hygiene procedures, including antibacterial, protective, moisturising agents after individual oral health assessment.
Subject(s)
COVID-19 , Dental Caries , Noninvasive Ventilation , Humans , Female , Male , Middle Aged , Aged , Aged, 80 and over , Noninvasive Ventilation/adverse effects , Prevalence , Interleukin-6 , COVID-19/complications , COVID-19/epidemiology , SARS-CoV-2 , OxygenABSTRACT
BACKGROUND: In the last decades, noninvasive ventilation (NIV) has been increasingly used to support patients with hypercapnic and hypoxemic acute respiratory failure. Pressure ulcers are a frequently observed NIV-related adverse effect, directly related to interface type and exposure time. Switching to a different interface has been proposed as a solution to improve patient comfort. However, large studies investigating the benefit of this strategy are not available. Thus, the aim of the ROTAtional-USE of interface STUDY (ROTA-USE STUDY) is to investigate whether a protocolized rotational use of interfaces during NIV is effective in reducing the incidence of pressure ulcers. METHODS: The ROTA-USE STUDY is a pragmatic, parallel arm, open-label, multicenter, spontaneous, non-profit, randomized controlled trial requiring non-significant risk medical devices, with the aim to determine whether a rotational strategy of NIV interfaces is associated with a lower incidence of pressure ulcers compared to the standard of care. In the intervention group, NIV mask will be randomly chosen and rotated every 6 h. In the control group, mask will be chosen according to the standard of care of the participating centers and changed in case of discomfort or in the presence of new pressure sores. In both groups, the skin underneath the mask will be inspected every 12 h for any possible damage by blinded assessors. The primary outcome is the proportion of patients developing new pressure sores at 36 h from randomization. The secondary outcomes are (i) onset of pressure sores measured at different time points, i.e., 12, 24, 36, 48, 60, 72, 84, and 96 h; (ii) number and stage of pressure sores and comfort measured at 12, 24, 36, 48, 60, 72, 84, and 96 h; and (iii) the economic impact of the protocolized rotational use of interfaces. A sample size of 239 subjects per group (intervention and control) is estimated to detect a 10% absolute difference in the proportion of patients developing pressure sores at 36 h. DISCUSSION: The development of pressure ulcers is a common side effect of NIV that negatively affects the patients' comfort and tolerance, often leading to NIV failure and adverse outcomes. The ROTA-USE STUDY will determine whether a protocolized rotational approach can reduce the incidence, number, and severity of pressure ulcers in NIV-treated patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT05513508. Registered on August 24, 2022.
Subject(s)
Noninvasive Ventilation , Positive-Pressure Respiration , Respiratory Insufficiency , Humans , Noninvasive Ventilation/adverse effects , Noninvasive Ventilation/methods , Positive-Pressure Respiration/adverse effects , Positive-Pressure Respiration/methods , Pressure Ulcer/epidemiology , Pressure Ulcer/prevention & control , Respiratory Insufficiency/therapy , Standard of Care , Adult , Treatment OutcomeABSTRACT
BACKGROUND: Endotracheal intubation is a common procedure associated with adverse events, including severe desaturation. Many patients receive noninvasive respiratory support to reduce the need for intubation. There are minimal data about the association between noninvasive respiratory support and the risk of a severe desaturation event during intubation. We aim to differentiate patients based on the level of noninvasive respiratory support, analyze the severe desaturation event by groups, and identify modifiable risk factors. METHODS: Oral intubations, excluding tube exchanges or re-intubation after unplanned extubation, from October 2018 through July 2020, at the study site were reviewed. A severe desaturation event was defined as [Formula: see text] < 70% or a >15% decrease from baseline in cyanotic heart disease. We analyzed outcomes by 4 groups: room air/nasal cannula (≤0.5 L/kg/min), high-flow nasal cannula (HFNC) (0.5-2 L/kg/min), high HFNC (≥2 L/kg/min), and noninvasive ventilation (NIV). RESULTS: Of 243 subjects who were intubated, 31% were receiving room air/nasal cannula, 25% were receiving HFNC, 18% were receiving high HFNC, and 26% were receiving NIV. Twelve percent of all the subjects had a severe desaturation event. In a univariate analysis, the incidence of a severe desaturation event was similar among all levels of respiratory support (P = .14). A severe desaturation event was more likely in those subjects who were receiving [Formula: see text] ≥ 0.6 at the time of the decision to intubate (19.6%) versus [Formula: see text] < 0.6 (8.1%) (P = .02). The duration of noninvasive respiratory support was longer (5 vs 1 h; P = .02) among those with a severe desaturation event. In a regression analysis, when adjusting for ≥2 intubation attempts pre-intubation, NIV use was independently associated with increased odds of severe desaturation events (odds ratio 3.14, CI 1.08-10.5). CONCLUSIONS: Results of our study suggest that [Formula: see text] > 0.60, the duration of noninvasive respiratory support, and exposure to NIV before an intubation are risk factors of severe desaturation events during intubation.
Subject(s)
Noninvasive Ventilation , Respiratory Insufficiency , Humans , Child , Respiratory Insufficiency/etiology , Respiratory Insufficiency/therapy , Intensive Care Units , Intubation, Intratracheal/adverse effects , Intubation, Intratracheal/methods , Respiration, Artificial , Cannula , Noninvasive Ventilation/adverse effects , Noninvasive Ventilation/methods , Oxygen Inhalation TherapyABSTRACT
Patients with hypercapnic COPD appear to represent a phenotype driven by specific physiology including air trapping and mechanical disadvantage, sleep hypoventilation, and sleep apnea. Such individuals appear to be at high risk for adverse health outcomes. Home noninvasive ventilation (NIV) has been shown to have the potential to help compensate for physiological issues underlying hypercapnia. In contrast to older literature, contemporary clinical trials of home NIV have been shown to improve patient-oriented outcomes including quality of life, hospitalizations, and mortality. Advancements in the use of NIV, including the use of higher inspiratory pressures, may account for recent success. Successful practical application of home NIV thus requires an adequate understanding of patient selection, devices and modes, and strategies for titration. The emergence of telemonitoring holds promise for further improvements in patient care by facilitating titration, promoting adherence, troubleshooting issues, and possibly predicting exacerbations. Given the complexity of home NIV, clinicians and health systems might consider establishment of dedicated home ventilation programs to provide such care. In addition, incorporation of respiratory therapist expertise is likely to improve success. Traditional fee-for-service structures have been a challenge for financing such programs, but ongoing changes toward value-based care are likely to make home NIV programs more feasible.
Subject(s)
Noninvasive Ventilation , Pulmonary Disease, Chronic Obstructive , Respiratory Insufficiency , Humans , Noninvasive Ventilation/adverse effects , Quality of Life , Lung , Hypercapnia/etiology , Hypercapnia/therapy , Respiratory Insufficiency/etiology , Respiratory Insufficiency/therapyABSTRACT
The utilization of noninvasive ventilation (NIV) in pediatric intensive care units (PICUs), to support children with respiratory failure and avoid endotracheal intubation, has increased. Current guidelines recommend initiating enteral nutrition (EN) within the first 24-48 h post admission. This practice remains variable among PICUs due to perceptions of a lack of safety data and the potential increase in respiratory and gastric complications. The objective of this retrospective study was to evaluate the association between EN and development of extraintestinal complications in children 0-18 years of age on NIV for acute respiratory failure. Of 332 patients supported with NIV, 249 (75%) were enterally fed within the first 48 h of admission. Respiratory complications occurred in 132 (40%) of the total cohort and predominantly in non-enterally fed patients (60/83, 72% vs. 72/249, 29%; p < 0.01), and they occurred earlier during ICU admission (0 vs. 2 days; p < 0.01). The majority of complications were changes in the fraction of inspired oxygen (220/290, 76%). In the multivariate evaluation, children on bilevel positive airway pressure (BiPAP) (23/132, 17% vs. 96/200, 48%; odds ratio [OR] = 5.3; p < 0.01), receiving a higher fraction of inspired oxygen (FiO2) (0.42 vs. 0.35; OR = 6; p = 0.03), and with lower oxygen saturation (SpO2) (91% vs. 97%; OR = 0.8; p < 0.01) were more likely to develop a complication. Time to discharge from the intensive care unit (ICU) was longer for patients with complications (11 vs. 3 days; OR = 1.12; p < 0.01). The large majority of patients requiring NIV can be enterally fed without an increase in respiratory complications after an initial period of ICU stabilization.
Subject(s)
Critical Illness , Enteral Nutrition , Noninvasive Ventilation , Child , Humans , Critical Illness/therapy , Enteral Nutrition/adverse effects , Noninvasive Ventilation/adverse effects , Oxygen , Retrospective Studies , Intensive Care Units, PediatricABSTRACT
PULSE OXIMETRY AND BLOOD GAS ANALYSES: Pulse oximetry has high sensitivity but low specificity for detecting hypoxemia. Arterial blood gas analyses are the gold standard for monitoring O2 therapy. Venous blood gas analyses should not be used in this setting. TARGET VALUES OF O2 THERAPY: The target range of acute O2 therapy for ventilated patients and nonventilated patients not at risk of hypercapnia should be between 92% and 96% for oxygen saturation (SpO2) measured by pulse oximetry. Indications for high-dose O2 therapy without a target range in critical care include carbon monoxide poisoning and patients with severe respiratory distress when SpO2 cannot be derived. Hyperoxemia, i.e., SpO2 values above 96%, has not improved survival in randomized trials of predominantly ventilated ICU patients. Under hyperoxemia in nonventilated patients at risk of hypercapnia (e.g., patients with chronic obstructive pulmonary disease), one in three patients is at risk of increasing carbon dioxide. Therefore, a target SpO2 of 88-92% should be aimed for in these patients. O2 TARGET RANGES ON EXTRACORPOREAL PROCEDURES: There are no randomized studies recommending other SpO2 target ranges for patients on extracorporeal procedures. These patients should always be monitored with arterial blood gases-in the case of peripheral VA-ECMO on the right arm and downstream of the oxygenator. HIGH-FLOW OXYGEN THERAPY FOR ACUTE HYPERCAPNIC RESPIRATORY FAILURE: High-flow oxygen therapy (HFNC) was not associated with reduced in-hospital mortality compared with conventional O2 in a meta-analysis of predominantly patients with acute hypoxemia (type I respiratory failure), although intubation rates were reduced. Also, in acute hypercapnic respiratory failure (type II), HFNC with high flow rates is not inferior to noninvasive ventilation (NIV).