ABSTRACT
In a sixty-eight-bed level-IV NICU, an increased incidence of hospital-acquired pressure injuries (HAPIs) from noninvasive ventilation (NIV) devices was identified. The aim of this quality improvement project was to decrease HAPIs from NIV by 10%. A literature review and the Plan-Do-Study-Act were implemented. The intervention included a customized silicone foam dressing under NIV, an NIV skincare bundle, and multidisciplinary support. Hospital-acquired pressure injury rates were tracked over 3 years postinterventions. The incidence of HAPIs declined by 20% from 0.2 per 1,000 patient days to 0.05 per 1,000 patient days. Relative risk was 4.6 times greater prior to intervention (p = .04). Continuous positive airway pressure (CPAP) failure was not noted and measured by the percentage of patients on ventilators pre- and postintervention. Customized silicone foam dressings under NIV, NIV skincare bundle, and multidisciplinary team support may decrease HAPIs in neonates without CPAP failure.
Subject(s)
Bandages , Noninvasive Ventilation , Pressure Ulcer , Humans , Infant, Newborn , Pressure Ulcer/prevention & control , Noninvasive Ventilation/methods , Noninvasive Ventilation/nursing , Noninvasive Ventilation/instrumentation , Female , Quality Improvement , Intensive Care Units, Neonatal , Male , Silicones , Patient Care Bundles/methods , Skin Care/methods , Skin Care/nursing , Iatrogenic Disease/prevention & controlABSTRACT
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
BACKGROUND: CO2 rebreathing is one of the risks associated with noninvasive ventilation (NIV), possibly contributing to failure. In a bench study, we showed that a novel mask design, with separate limbs for inflow and outflow gases, significantly reduced CO2 rebreathing in different ventilation settings. OBJECTIVES: The study aimed to test whether a new mask design could 1) reduce CO2 rebreathing in healthy volunteers during NIV (phase 1) and 2) reduce minute ventilation (phase 2). MATERIALS AND METHODS: Healthy volunteers were randomly assigned to NIV using two masks in a crossover design: a traditional single-limb mask for inflow and outflow gases and a mask with two separated limbs. In phase 1, six ventilation settings were tested for each mask: CPAP (PEEP 5 cmH2O) and pressure support ventilation (PSV, PS Level 5 cmH2O) using a mechanical ventilator with a bias flow of 8 or 20 L/min; free-flow CPAP (PEEP 5 cmH2O) with 60 or 90 L/min of gas flow. A nasal cannula was inserted in one nostril of the volunteers and connected to a CO2 gas analyzer to measure CO2 during the respiratory cycle. In phase 2, volunteers underwent a prolonged time of ventilation in CPAP 90 L/min and PSV with 20 L/min of bias flow. During free-flow CPAP, electrical impedance tomography was used to record the change in impedance during tidal breathing and then estimate tidal volume. RESULTS: Ten healthy adults were enrolled in phase 1, and 8 volunteers in phase 2. CO2 during inspiration was significantly lower in each setting with the two-limb versus the one-limb mask (p < 0.001). The maximum CO2 reduction was observed in the continuous-flow CPAP settings. EtCO2 was lower with the two-limb mask compared to the one-limb mask (p < 0.001). However, no difference in minute ventilation was observed between the two masks. CONCLUSION: The new mask design with two ports for inhaled and exhaled gases reduced the amount of CO2 rebreathing in all tested ventilation settings. The CO2 rebreathing reduction did not decrease minute ventilation in healthy volunteers.
Subject(s)
Masks , Noninvasive Ventilation , Adult , Humans , Carbon Dioxide , Gases , Healthy Volunteers , Noninvasive Ventilation/instrumentation , Respiration, Artificial , Cross-Over StudiesABSTRACT
During flexible fiberoptic bronchoscopy (FOB) the arterial partial pressure of oxygen can drop, increasing the risk for respiratory failure. To avoid desaturation episodes during the procedure several oxygenation strategies have been proposed, including conventional oxygen therapy (COT), high flow nasal cannula (HFNC), continuous positive airway pressure (CPAP) and non-invasive ventilation (NIV). By a review of the current literature, we merely describe the clinical practice of oxygen therapies during FOB. We also conducted a pooled data analysis with respect to oxygenation outcomes, comparing HFNC with COT and NIV, separately. COT showed its benefits in patients undergoing FOB for broncho-alveolar lavage (BAL) or brushing for cytology, in those with peripheral arterial oxyhemoglobin saturation < 93% prior to the procedure or affected by obstructive disorder. HFNC is preferable over COT in patients with mild to moderate acute respiratory failure (ARF) undergoing FOB, by improving oxygen saturation and decreasing the episodes of desaturation. On the opposite, CPAP and NIV guarantee improved oxygenation outcomes as compared to HFNC, and they should be preferred in patients with more severe hypoxemic ARF during FOB.
Subject(s)
Bronchoscopy/methods , Lung Diseases/therapy , Oxygen Inhalation Therapy/methods , Oxygen Saturation/physiology , Pliability , Bronchoscopy/instrumentation , Humans , Lung Diseases/diagnosis , Noninvasive Ventilation/instrumentation , Noninvasive Ventilation/methods , Observational Studies as Topic/methods , Oxygen Inhalation Therapy/instrumentation , Randomized Controlled Trials as Topic/methodsABSTRACT
BACKGROUND: Long-term non-invasive ventilation (NIV) is as an established treatment option for chronic hypercapnic COPD patients. Beneficial effects have also been shown during exercise, but this is restricted to rehabilitation programs. New portable NIV (pNIV) devices may now enable NIV application during walking at home. STUDY DESIGN AND METHODS: In two randomized crossover trials, the impact of pNIV on dyspnea and endurance capacity was investigated in patients with moderate to severe COPD. Participants performed a standardized 6-min walking test, with and without pNIV, using a pre-set inspiratory/expiratory positive airway pressure of 18/8 cmH2O. The first study was performed in NIV-naïve patients (Study I), while the second study was performed in those already established on long-term NIV (Study II). RESULTS: 38 patients (66.9 ± 7.4 years, mean FEV1: 30.3 ± 8%pred) and 23 patients (67.6 ± 8.7 years, mean FEV1: 29.8 ± 10.4%pred) participated in Study I and II, respectively. In Study I, the mean difference in the Borg Dyspnea Scale (BDS, primary outcome) score following walking was 3.2 (IQR 2-4) without pNIV, compared to 2.6 (IQR 1-4) with pNIV (ΔBDS 0.65, P = 0.04), while walking distance increased from 311.8 m (95%CI 276.9-346.6 m) to 326.3 m (95%CI 291.5-361.2 m) (P = 0.044) when pNIV was used. Accordingly, in Study II, the mean difference in BDS was 4.4 (IQR 3-6) without pNIV, compared to 4.5 (IQR 3-6) with pNIV (ΔBDS 0.09, P = 0.54), while walking distance decreased from 291.5 m (95%CI 246.1-336.9 m) to 258.4 m (95%CI 213-303.8 m) (P ≤ 0.001). INTERPRETATION: The use of a pNIV device during walking can improve dyspnea and walking distance in patients with moderate to severe COPD. Patients who do not already receive long-term NIV therapy are more likely to benefit compared to those undergoing long-term NIV. Careful patient selection is mandatory. Clinical Trial Register: DRKS00013203; DRKS00012913 registered October 20th 2017 and October 16th 2017; https://www.drks.de/drks_web/.
Subject(s)
Dyspnea/therapy , Lung/physiopathology , Noninvasive Ventilation/instrumentation , Pulmonary Disease, Chronic Obstructive/therapy , Ventilators, Mechanical , Aged , Cross-Over Studies , Dyspnea/diagnosis , Dyspnea/physiopathology , Equipment Design , Exercise Tolerance , Female , Forced Expiratory Volume , Germany , Humans , Male , Middle Aged , Noninvasive Ventilation/adverse effects , Pulmonary Disease, Chronic Obstructive/diagnosis , Pulmonary Disease, Chronic Obstructive/physiopathology , Recovery of Function , Severity of Illness Index , Time Factors , Treatment Outcome , Walk Test , WalkingABSTRACT
Delivery of medications to preterm neonates receiving non-invasive ventilation (NIV) represents one of the most challenging scenarios for aerosol medicine. This challenge is highlighted by the undersized anatomy and the complex (patho)physiological characteristics of the lungs in such infants. Key physiological restraints include low lung volumes, low compliance, and irregular respiratory rates, which significantly reduce lung deposition. Such factors are inherent to premature birth and thus can be regarded to as the intrinsic factors that affect lung deposition. However, there are a number of extrinsic factors that also impact lung deposition: such factors include the choice of aerosol generator and its configuration within the ventilation circuit, the drug formulation, the aerosol particle size distribution, the choice of NIV type, and the patient interface between the delivery system and the patient. Together, these extrinsic factors provide an opportunity to optimize the lung deposition of therapeutic aerosols and, ultimately, the efficacy of the therapy.In this review, we first provide a comprehensive characterization of both the intrinsic and extrinsic factors affecting lung deposition in premature infants, followed by a revision of the clinical attempts to deliver therapeutic aerosols to premature neonates during NIV, which are almost exclusively related to the non-invasive delivery of surfactant aerosols. In this review, we provide clues to the interpretation of existing experimental and clinical data on neonatal aerosol delivery and we also describe a frame of measurable variables and available tools, including in vitro and in vivo models, that should be considered when developing a drug for inhalation in this important but under-served patient population.
Subject(s)
Bronchodilator Agents/administration & dosage , Drug Delivery Systems/methods , Nebulizers and Vaporizers , Noninvasive Ventilation/methods , Premature Birth/drug therapy , Respiratory Mechanics/drug effects , Administration, Inhalation , Aerosols , Drug Delivery Systems/instrumentation , Humans , Infant, Newborn , Noninvasive Ventilation/instrumentation , Premature Birth/diagnosis , Premature Birth/physiopathology , Respiratory Mechanics/physiologyABSTRACT
A helmet, comprising a transparent hood and a soft collar, surrounding the patient's head can be used to deliver noninvasive ventilatory support, both as continuous positive airway pressure and noninvasive positive pressure ventilation (NPPV), the latter providing active support for inspiration. In this review, we summarize the technical aspects relevant to this device, particularly how to prevent CO2 rebreathing and improve patient-ventilator synchrony during NPPV. Clinical studies describe the application of helmets in cardiogenic pulmonary oedema, pneumonia, COVID-19, postextubation and immune suppression. A section is dedicated to paediatric use. In summary, helmet therapy can be used safely and effectively to provide NIV during hypoxemic respiratory failure, improving oxygenation and possibly leading to better patient-centred outcomes than other interfaces.
Subject(s)
Interactive Ventilatory Support/methods , Noninvasive Ventilation/methods , Work of Breathing/physiology , COVID-19 , Humans , Monitoring, Physiologic/methods , Noninvasive Ventilation/instrumentation , Respiratory Insufficiency/therapyABSTRACT
Noninvasive continuous positive airway pressure (NIV-CPAP) is effective in patients with hypoxemic respiratory failure. Building evidence during the COVID-19 emergency reported that around 50% of patients in Italy treated with NIV-CPAP avoided the need for invasive mechanical ventilation. Standard NIV-CPAP systems operate at high gas flow rates responsible for noise generation and inadequate humidification. Furthermore, open-configuration systems require a high concentration of oxygen to deliver the desired FiO2 . Concerns outlined the risk for aerosolization in the ambient air and the possible pressure drop in hospital supply pipes. A new NIV-CPAP system is proposed that includes automatic control of patient respiratory parameters. The system operates as a closed-loop breathing circuit that can be assembled, combining a sleep apnea machine with existing commercially available components. Analytical simulation of a breathing patient and simulation with a healthy volunteer at different FiO2 were performed. Inspired and expired oxygen fraction and inspired and expired carbon dioxide pressure were recorded at different CPAP levels with different oxygen delivery. Among the main findings, we report (a) a significant (up to 30-fold) reduction in oxygen feeding compared to standard open high flow NIV-CPAP systems, to assure the same FiO2 levels, and (b) a negligible production of the noise generated in ventilatory systems, and consequent minimization of patients' discomfort. The proposed NIV-CPAP circuit, reshaped in closed-loop configuration with the blower outside of the circuit, has the advantages of minimizing aerosol generation, environmental contamination, oxygen consumption, and noise to the patient. The system is easily adaptable and can be implemented using standard CPAP components.
Subject(s)
COVID-19/therapy , Continuous Positive Airway Pressure/instrumentation , Lung/virology , Noise/prevention & control , Noninvasive Ventilation/instrumentation , Oxygen/administration & dosage , SARS-CoV-2/pathogenicity , Ventilators, Mechanical , Aerosols , COVID-19/physiopathology , COVID-19/transmission , COVID-19/virology , Computer Simulation , Continuous Positive Airway Pressure/adverse effects , Equipment Design , Filtration/instrumentation , Humans , Lung/physiopathology , Noise/adverse effects , Noninvasive Ventilation/adverse effects , Numerical Analysis, Computer-Assisted , Oxygen/adverse effectsABSTRACT
Rationale: High-flow nasal cannula (HFNC) and helmet noninvasive ventilation (NIV) are used for the management of acute hypoxemic respiratory failure.Objectives: Physiological comparison of HFNC and helmet NIV in patients with hypoxemia.Methods: Fifteen patients with hypoxemia with PaO2/FiO2 < 200 mm Hg received helmet NIV (positive end-expiratory pressure ≥ 10 cm H2O, pressure support = 10-15 cm H2O) and HFNC (50 L/min) in randomized crossover order. Arterial blood gases, dyspnea, and comfort were recorded. Inspiratory effort was estimated by esophageal pressure (Pes) swings. Pes-simplified pressure-time product and transpulmonary pressure swings were measured.Measurements and Main Results: As compared with HFNC, helmet NIV increased PaO2/FiO2 (median [interquartile range]: 255 mm Hg [140-299] vs. 138 [101-172]; P = 0.001) and lowered inspiratory effort (7 cm H2O [4-11] vs. 15 [8-19]; P = 0.001) in all patients. Inspiratory effort reduction by NIV was linearly related to inspiratory effort during HFNC (r = 0.84; P < 0.001). Helmet NIV reduced respiratory rate (24 breaths/min [23-31] vs. 29 [26-32]; P = 0.027), Pes-simplified pressure-time product (93 cm H2O â s â min-1 [43-138] vs. 200 [168-335]; P = 0.001), and dyspnea (visual analog scale 3 [2-5] vs. 8 [6-9]; P = 0.002), without affecting PaCO2 (P = 0.80) and comfort (P = 0.50). In the overall cohort, transpulmonary pressure swings were not different between treatments (NIV = 18 cm H2O [14-21] vs. HFNC = 15 [8-19]; P = 0.11), but patients exhibiting lower inspiratory effort on HFNC experienced increases in transpulmonary pressure swings with helmet NIV. Higher transpulmonary pressure swings during NIV were associated with subsequent need for intubation.Conclusions: As compared with HFNC in hypoxemic respiratory failure, helmet NIV improves oxygenation, reduces dyspnea, inspiratory effort, and simplified pressure-time product, with similar transpulmonary pressure swings, PaCO2, and comfort.
Subject(s)
Hypoxia/physiopathology , Hypoxia/therapy , Noninvasive Ventilation/instrumentation , Respiratory Insufficiency/physiopathology , Respiratory Insufficiency/therapy , Acute Disease , Aged , Cannula , Cross-Over Studies , Female , Humans , Hypoxia/complications , Male , Middle Aged , Respiratory Insufficiency/complicationsABSTRACT
STUDY OBJECTIVE: To determine whether non-invasive ventilation (NIV) delivered by helmet continuous positive airway pressure (hCPAP) is non-inferior to facemask continuous positive airway pressure (fCPAP) in patients with acute respiratory failure in the emergency department (ED). METHODS: Non-inferiority randomized, clinical trial involving patients presenting with acute respiratory failure conducted in the ED of a local hospital. Participants were randomly allocated to receive either hCPAP or fCPAP as per the trial protocol. The primary endpoint was respiratory rate reduction. Secondary endpoints included discomfort, improvement in Dyspnea and Likert scales, heart rate reduction, arterial blood oxygenation, partial pressure of carbon dioxide (PaCO2), dryness of mucosa and intubation rate. RESULTS: 224 patients were included and randomized (113 patients to hCPAP, 111 to fCPAP). Both techniques reduced respiratory rate (hCPAP: from 33.56 ± 3.07 to 25.43 ± 3.11 bpm and fCPAP: from 33.46 ± 3.35 to 27.01 ± 3.19 bpm), heart rate (hCPAP: from 114.76 ± 15.5 to 96.17 ± 16.50 bpm and fCPAP: from 115.07 ± 14.13 to 101.19 ± 16.92 bpm), and improved dyspnea measured by both the Visual Analogue Scale (hCPAP: from 16.36 ± 12.13 to 83.72 ± 12.91 and fCPAP: from 16.01 ± 11.76 to 76.62 ± 13.91) and the Likert scale. Both CPAP techniques improved arterial oxygenation (PaO2 from 67.72 ± 8.06 mmHg to 166.38 ± 30.17 mmHg in hCPAP and 68.99 ± 7.68 mmHg to 184.49 ± 36.38 mmHg in fCPAP) and the PaO2:FiO2 (Partial pressure of arterial oxygen: Fraction of inspired oxygen) ratio from 113.6 ± 13.4 to 273.4 ± 49.5 in hCPAP and 115.0 ± 12.9 to 307.7 ± 60.9 in fCPAP. The intubation rate was lower with hCPAP (4.4% for hCPAP versus 18% for fCPAP, absolute difference -13.6%, p = 0.003). Discomfort and dryness of mucosa were also lower with hCPAP. CONCLUSION: In patients presenting to the ED with acute cardiogenic pulmonary edema or decompensated COPD, hCPAP was non-inferior to fCPAP and resulted in greater comfort levels and lower intubation rate.
Subject(s)
Continuous Positive Airway Pressure/instrumentation , Head Protective Devices/standards , Masks/standards , Respiratory Insufficiency/therapy , Aged , Continuous Positive Airway Pressure/standards , Continuous Positive Airway Pressure/statistics & numerical data , Emergency Service, Hospital/organization & administration , Emergency Service, Hospital/statistics & numerical data , Female , Head Protective Devices/statistics & numerical data , Humans , Male , Masks/statistics & numerical data , Middle Aged , Noninvasive Ventilation/instrumentation , Noninvasive Ventilation/methodsABSTRACT
BACKGROUND: The use of high-flow nasal cannula (HFNC) and noninvasive ventilation (NIV) in patients with COVID-19 is debated. METHODS: This study was performed in four hospitals of China from January to March 2020. We retrospectively enrolled 23 and 13 COVID-19 patients who used HFNC and NIV as first-line therapy, respectively. RESULTS: Among the 23 patients who used HFNC as first-line therapy, 10 experienced HFNC failure and used NIV as rescue therapy. Among the 13 patients who used NIV as first-line therapy, one (8%) used HFNC as rescue therapy due to NIV intolerance. The duration of HFNC + NIV (median 7.1, IQR: 3.5-12.2 vs. 7.3, IQR: 5.3-10.0 days), intubation rate (17% vs. 15%) and mortality (4% vs. 8%) did not differ between patients who used HFNC and NIV as first-line therapy. In total cohorts, 6 (17%) patients received intubation. Time from initiation of HFNC or NIV to intubation was 8.4 days (IQR: 4.4-18.5). And the time from initiation of HFNC or NIV to termination in patients without intubation was 7.1 days (IQR: 3.9-10.3). Among all the patients, C-reactive protein was independently associated with intubation (OR = 1.04, 95% CI: 1.01-1.07). In addition, no medical staff got nosocomial infection who participated in HFNC and NIV management. CONCLUSIONS: In critically ill patients with COVID-19 who used HFNC and NIV as first-line therapy, the duration of HFNC + NIV, intubation rate and mortality did not differ between two groups. And no medical staff got nosocomial infection during this study.
Subject(s)
COVID-19/therapy , Cannula/statistics & numerical data , Noninvasive Ventilation/instrumentation , Oxygen Inhalation Therapy/instrumentation , Aged , COVID-19/epidemiology , China/epidemiology , Equipment Design , Female , Humans , Male , Middle Aged , Pandemics , SARS-CoV-2ABSTRACT
BACKGROUND: Initial recommendations discouraged high flow nasal cannula (HFNC) in COVID-19 patients, driven by concern for healthcare worker (HCW) exposure. Noting high morbidity and mortality from early invasive mechanical ventilation, we implemented a COVID-19 respiratory protocol employing HFNC in severe COVID-19 and HCW exposed to COVID-19 patients on HFNC wore N95/KN95 masks. Utilization of HFNC increased significantly but questions remained regarding HCW infection rate. METHODS: We performed a retrospective evaluation of employee infections in our healthcare system using the Employee Health Services database and unit records of employees tested between March 15, 2020 and May 23, 2020. We assessed the incidence of infections before and after the implementation of the protocol, stratifying by clinical or non-clinical role as well as inpatient COVID-19 unit. RESULTS: During the study period, 13.9% (228/1635) of employees tested for COVID-19 were positive. Forty-six percent of infections were in non-clinical staff. After implementation of the respiratory protocol, the proportion of positive tests in clinical staff (41.5%) was not higher than that in non-clinical staff (43.8%). Of the clinicians working in the high-risk COVID-19 unit, there was no increase in infections after protocol implementation compared with clinicians working in COVID-19 units that did not use HFNC. CONCLUSION: We found no evidence of increased COVID-19 infections in HCW after the implementation of a respiratory protocol that increased use of HFNC in patients with COVID-19; however, these results are hypothesis generating.
Subject(s)
COVID-19/epidemiology , COVID-19/therapy , Health Personnel/statistics & numerical data , Noninvasive Ventilation/methods , Occupational Diseases/epidemiology , Cannula , Humans , Massachusetts/epidemiology , Noninvasive Ventilation/instrumentation , Occupational Exposure , Retrospective Studies , Tertiary Care CentersABSTRACT
Importance: High-flow nasal oxygen is recommended as initial treatment for acute hypoxemic respiratory failure and is widely applied in patients with COVID-19. Objective: To assess whether helmet noninvasive ventilation can increase the days free of respiratory support in patients with COVID-19 compared with high-flow nasal oxygen alone. Design, Setting, and Participants: Multicenter randomized clinical trial in 4 intensive care units (ICUs) in Italy between October and December 2020, end of follow-up February 11, 2021, including 109 patients with COVID-19 and moderate to severe hypoxemic respiratory failure (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ≤200). Interventions: Participants were randomly assigned to receive continuous treatment with helmet noninvasive ventilation (positive end-expiratory pressure, 10-12 cm H2O; pressure support, 10-12 cm H2O) for at least 48 hours eventually followed by high-flow nasal oxygen (n = 54) or high-flow oxygen alone (60 L/min) (n = 55). Main Outcomes and Measures: The primary outcome was the number of days free of respiratory support within 28 days after enrollment. Secondary outcomes included the proportion of patients who required endotracheal intubation within 28 days from study enrollment, the number of days free of invasive mechanical ventilation at day 28, the number of days free of invasive mechanical ventilation at day 60, in-ICU mortality, in-hospital mortality, 28-day mortality, 60-day mortality, ICU length of stay, and hospital length of stay. Results: Among 110 patients who were randomized, 109 (99%) completed the trial (median age, 65 years [interquartile range {IQR}, 55-70]; 21 women [19%]). The median days free of respiratory support within 28 days after randomization were 20 (IQR, 0-25) in the helmet group and 18 (IQR, 0-22) in the high-flow nasal oxygen group, a difference that was not statistically significant (mean difference, 2 days [95% CI, -2 to 6]; P = .26). Of 9 prespecified secondary outcomes reported, 7 showed no significant difference. The rate of endotracheal intubation was significantly lower in the helmet group than in the high-flow nasal oxygen group (30% vs 51%; difference, -21% [95% CI, -38% to -3%]; P = .03). The median number of days free of invasive mechanical ventilation within 28 days was significantly higher in the helmet group than in the high-flow nasal oxygen group (28 [IQR, 13-28] vs 25 [IQR 4-28]; mean difference, 3 days [95% CI, 0-7]; P = .04). The rate of in-hospital mortality was 24% in the helmet group and 25% in the high-flow nasal oxygen group (absolute difference, -1% [95% CI, -17% to 15%]; P > .99). Conclusions and Relevance: Among patients with COVID-19 and moderate to severe hypoxemia, treatment with helmet noninvasive ventilation, compared with high-flow nasal oxygen, resulted in no significant difference in the number of days free of respiratory support within 28 days. Further research is warranted to determine effects on other outcomes, including the need for endotracheal intubation. Trial Registration: ClinicalTrials.gov Identifier: NCT04502576.
Subject(s)
COVID-19/complications , Intubation, Intratracheal/statistics & numerical data , Noninvasive Ventilation/instrumentation , Oxygen Inhalation Therapy/methods , Respiratory Insufficiency/therapy , Aged , COVID-19/mortality , COVID-19/therapy , Female , Hospital Mortality , Humans , Hypoxia/etiology , Male , Middle Aged , Noninvasive Ventilation/methods , Respiratory Insufficiency/etiology , Treatment FailureABSTRACT
Cardio-renal syndrome is a challenging clinical entity to manage, and is often associated with increased morbidity and mortality. We hypothesized that adaptive servo-ventilation (ASV), non-invasive positive pressure ventilation that ameliorates systemic/pulmonary congestion, may improve renal function in patients with symptomatic heart failure complicated by the cardio-renal syndrome. Patients with symptomatic congestive heart failure who underwent ASV therapy for over 1 month were included in this retrospective study. The trajectory of the estimated glomerular filtration ratio (eGFR) between the pre-1 month period and the post-one-month period (on ASV) were compared. A total of 81 patients (median 65 years old, 65 men) were included. eGFR decreased during the pre-1 month period from 52.7 (41.7, 64.6) down to 49.9 (37.3, 63.5) mL/minute/1.73 m2 (P < 0.001) whereas we observed an increase following one-month of ASV therapy up to 53.4 (38.6, 68.6) mL/minute/1.73 m2 (P = 0.022). A reduction in furosemide equivalent dose following the initiation of ASV therapy was independently associated with increases in eGFR with an adjusted odds ratio of 13.72 (95% confidence interval 3.40-55.3, P < 0.001). In conclusion, short-term ASV therapy was associated with the preservation of renal function, particularly when the dose of loop diuretics was concomitantly reduced.
Subject(s)
Cardio-Renal Syndrome/therapy , Heart Failure/therapy , Kidney/physiopathology , Noninvasive Ventilation/instrumentation , Positive-Pressure Respiration/methods , Aged , Cardio-Renal Syndrome/epidemiology , Cardio-Renal Syndrome/etiology , Cardio-Renal Syndrome/mortality , Diuretics/administration & dosage , Diuretics/therapeutic use , Drug Tapering/statistics & numerical data , Female , Furosemide/administration & dosage , Furosemide/therapeutic use , Glomerular Filtration Rate/physiology , Heart Failure/complications , Heart Failure/physiopathology , Hemodynamics/drug effects , Hemodynamics/physiology , Humans , Kidney Function Tests , Male , Middle Aged , Retrospective StudiesABSTRACT
During the beginning of the SARS-CoV-2 pandemic, there was a shortage of masks and respirators for the protection of health care professionals. Masks for noninvasive ventilation (NIV) in combination with viral-proof filters, worn by healthcare workers, could serve as an alternative protection measure. We determined the simulated protection factor (SPF) of such devices in comparison to conventional surgical masks, N95, and FFP3 respirators. Masks and respirators were mounted on a ventilated mannequin head in a test-chamber. Isotonic saline containing 150 MBq 99mTC-DTPA (99mTc-diethylenetriamine pentaacetate (DTPA) was nebulized inside the box. The aerosol had a mass median aerodynamic diameter of 0.6 ± 0.4 µm. SPFs were measured using radioactive DTPA particles in the mannequin test system by calculating the ratio of unfiltered particles (Pu) and filtered particles (Pf) for each tested device (SPF = Pu/Pf). Simulated protection factors were 15.6 ± 3.6 for a ResMed AcuCare mask plus filter, 3.5 ± 0.2 for a ResMed Mirage Quattro FX mask plus filter, 9.5 ± 0.8 for a Loewenstein JOYCEclinc FF mask plus filter, 1.9 ± 0.2 for a surgical mask with a rubber band, 2.7 ± 0.7 for a surgical mask with ribbons, 2.3 ± 0.3 for an FFP3 respirator, and 3.6 ± 1.3 for an N95 respirator. The ResMed AcuCare and the Loewenstein JOYCEclinic FF mask were more effective than any other of the tested devices (p < 0.001). In conclusion, masks normally used for NIV with viral-proof filters can effectively filter respirable particles.
Subject(s)
COVID-19/prevention & control , Masks , Respiratory Protective Devices , Filtration/instrumentation , Manikins , N95 Respirators , Noninvasive Ventilation/instrumentation , Occupational Exposure/prevention & control , SARS-CoV-2 , Technetium Tc 99m PentetateABSTRACT
Helmet-based noninvasive ventilation (NIV) is a viable option for the safe transport of potential or known coronavirus disease 2019 patients. Given the most likely modes of transmission through droplets, aerosols, and fomite contact, airway procedures such as endotracheal intubation place air medical crews and other health care providers at high risk for exposure. This, together with data that suggest that a large cohort of coronavirus disease 2019 patients have better outcomes if we can avoid intubating them, creates a need for a safe method of NIV or high-flow oxygen delivery during transport. Commonly used and successful in-hospital regimens for these patients are high-flow nasal cannula and continuous positive airway pressure or bilevel positive airway pressure. In some studies, helmet NIV has been shown to be a viable, if not superior, alternative to these therapies for patients with acute hypoxemic respiratory failure. Furthermore, because it is a sealed and closed space that completely isolates the patient's airway and breathing, it provides a very high degree of protection from exposure to pathogens transmitted through droplets or aerosols. This article discusses practical implementation of helmet NIV in air medical transport.
Subject(s)
Air Ambulances , COVID-19/therapy , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Noninvasive Ventilation/instrumentation , COVID-19/transmission , Humans , Noninvasive Ventilation/methodsABSTRACT
BACKGROUND: Noninvasive ventilation (NIV) represents an effective treatment for chronic respiratory failure. However, empirically determined NIV settings may not achieve optimal ventilatory support. Therefore, the efficacy of NIV should be systematically monitored. The minimal recommended monitoring strategy includes clinical assessment, arterial blood gases (ABG) and nocturnal transcutaneous pulsed oxygen saturation (SpO2). Polysomnography is a theoretical gold standard but is not routinely available in many centers. Simple tools such as transcutaneous capnography (TcPCO2) or ventilator built-in software provide reliable informations but their role in NIV monitoring has yet to be defined. The aim of our work was to compare the accuracy of different combinations of tests to assess NIV efficacy. METHODS: This retrospective comparative study evaluated the efficacy of NIV in consecutive patients through four strategies (A, B, C and D) using four different tools in various combinations. These tools included morning ABG, nocturnal SpO2, TcPCO2 and data provided by built-in software via a dedicated module. Strategy A (ABG + nocturnal SpO2), B (nocturnal SpO2 + TcPCO2) and C (TcPCO2 + builtin software) were compared to strategy D, which combined all four tools (NIV was appropriate if all four tools were normal). RESULTS: NIV was appropriate in only 29 of the 100 included patients. Strategy A considered 53 patients as appropriately ventilated. Strategy B considered 48 patients as appropriately ventilated. Strategy C misclassified only 6 patients with daytime hypercapnia. CONCLUSION: Monitoring ABG and nocturnal SpO2 is not enough to assess NIV efficacy. Combining data from ventilator built-in software and TcPCO2 seems to represent the best strategy to detect poor NIV efficacy. Trial registration Institutional Review Board of the Société de Pneumologie de Langue Française (CEPRO 2016 Georges).
Subject(s)
Blood Gas Analysis , Capnography , Lung/physiopathology , Noninvasive Ventilation , Polysomnography , Respiratory Insufficiency/therapy , Aged , Blood Gas Monitoring, Transcutaneous , Chronic Disease , Female , Humans , Male , Middle Aged , Noninvasive Ventilation/instrumentation , Predictive Value of Tests , Reproducibility of Results , Respiratory Insufficiency/diagnosis , Respiratory Insufficiency/physiopathology , Retrospective Studies , Software , Time Factors , Treatment Outcome , Ventilators, MechanicalABSTRACT
BACKGROUND: Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC) are modes of non-invasive respiratory support commonly used after extubation in extremely preterm infants. However, the cardiorespiratory physiology of these infants on each mode is unknown. METHODS: Prospective, randomized crossover study in infants with birth weight ≤1250 g undergoing their first extubation attempt. NCPAP and HFNC were applied randomly for 45 min each, while ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO2) were recorded. Respiratory signals were analyzed using an automated method, and differences between NCPAP and HFNC features and changes in FiO2 were analyzed. RESULTS: A total of 30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930 g [780, 1090] were studied. Infants were extubated at 5 days [2, 13] of life with 973 g [880, 1170] and three failed (10%). No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO2 levels (p = 0.02) during HFNC compared to NCPAP. CONCLUSIONS: In extremely preterm infants studied shortly after extubation, the use of HFNC was associated with longer respiratory pauses and higher FiO2 requirements.
Subject(s)
Cannula , Continuous Positive Airway Pressure/instrumentation , Device Removal , Infant, Extremely Premature , Infant, Very Low Birth Weight , Noninvasive Ventilation/instrumentation , Respiratory Distress Syndrome, Newborn/therapy , Respiratory Mechanics , Ventilator Weaning , Birth Weight , Cross-Over Studies , Female , Gestational Age , Humans , Male , Prospective Studies , Quebec , Respiratory Distress Syndrome, Newborn/diagnosis , Respiratory Distress Syndrome, Newborn/physiopathology , Time Factors , Treatment OutcomeABSTRACT
There are significant logistical challenges to providing respiratory support devices, beyond simple oxygen flow, when centres run out of supplies or do not have these devices at all, such as in low resource settings. At the peak of the COVID-19 crisis, it was extremely difficult to import medical equipment and supplies, because most countries prohibited the medical industry from selling outside of their own countries. As a consequence, engineering teams worldwide volunteered to develop emergency devices, and medical experts in mechanical ventilation helped to guide the design and evaluation of prototypes. Although regulations vary among countries, given the emergency situation, some Regulatory Agencies facilitated expedited procedures. However, laboratory and animal model testing are crucial to minimize the potential risk for patients when treated with a device that may worsen clinical outcome if poorly designed or misused.
Subject(s)
Continuous Positive Airway Pressure/instrumentation , Coronavirus Infections/therapy , Medical Device Legislation , Pneumonia, Viral/therapy , Respiratory Distress Syndrome/therapy , Respiratory Insufficiency/therapy , Ventilators, Mechanical/supply & distribution , Betacoronavirus , COVID-19 , Device Approval , Education, Professional, Retraining , Equipment Design , Equipment and Supplies/supply & distribution , Humans , Noninvasive Ventilation/instrumentation , Pandemics , Personnel Staffing and Scheduling , Respiration, Artificial/instrumentation , SARS-CoV-2 , SpainABSTRACT
Non-invasive ventilation (NIV) has dramatically changed the treatment of both acute and chronic respiratory failure in the last 2 decades. The success of NIV is correlated to the application of the "best ingredients" of a patient's "tailored recipe," including the appropriate choice of the selected candidate, the ventilator setting, the interface, the expertise of the team, and the education of the caregiver. The choice of the interface is crucial for the success of NIV. Type (oral, nasal, nasal pillows, oronasal, hybrid mask, helmet), size, design, material and headgears may affect the patient's comfort with respect to many aspects, such as air leaks, claustrophobia, skin erythema, eye irritation, skin breakdown, and facial deformity in children. Companies are paying great attention to mask development, in terms of shape, materials, comfort, and leak reduction. Although the continuous development of new products has increased the availability of interfaces and the chance to meet different requirements, in patients necessitating several daily hours of NIV, both in acute and in chronic home setting, the rotational use of different interfaces may remain an excellent strategy to decrease the risk of skin breakdown and to improve patient's tolerance. The aim of the present review was to give the readers a background on mask technology and materials in order to enhance their "knowledge" in making the right choice for the interface to apply during NIV in the different clinical scenarios.