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3.
J Clin Med ; 13(7)2024 Mar 29.
Artigo em Inglês | MEDLINE | ID: mdl-38610748

RESUMO

Background: Airway care interventions and prone positioning are used in critically ill patients with coronavirus disease 2019 (COVID-19) admitted to the intensive care unit (ICU) to improve oxygenation and facilitate mucus removal. At the onset of the COVID-19 pandemic, the decision-making process regarding the practice of airway care interventions and prone positioning was challenging. Objective: To provide an overview of the practice of airway care interventions and prone positioning during the second wave of the pandemic in the Netherlands. Method: Web-based survey design. Seventy ICU nurses, each representing one intensive care in the Netherlands, were contacted for participation. Potential items were generated based on a literature search and formulated by a multidisciplinary team. Questions were pilot tested for face and construct validity by four intensive care nurses from four different hospitals. Results: The response rate was 53/77 (69%). This survey revealed widespread use of airway care interventions in the Netherlands in COVID-19 patients, despite questionable benefits. Additionally, prone positioning was used in invasively and non-invasively ventilated patients. Conclusions: The use of airway care interventions and prone positioning is time consuming and comes with the production of waste. Further research is needed to assess the effectiveness, workload, and environmental impact of airway care interventions and prone positioning.

6.
Nurs Crit Care ; 28(6): 923-930, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-36464804

RESUMO

INTRODUCTION: Mechanical Insufflation-Exsufflation (MI-E) is used as an airway clearance intervention in primary care (home ventilation), long-term care (prolonged rehabilitation after intensive care, neuromuscular diseases, and spinal cord injury), and increasingly in acute care in intensive care units (ICU). AIM: We sought to develop in-depth understanding of factors influencing decision-making processes of health care professionals regarding initiation, escalation, de-escalation, and discontinuation of MI-E for invasively ventilated patients including perceived barriers and facilitators to use. METHODS: We conducted focus groups (3 in the Netherlands; 1 with participants from four European countries) with clinicians representing the ICU interprofessional team and with variable experience of MI-E. The semi-structured interview guide was informed by the Theoretical Domains Framework (TDF). Two researchers independently coded data for directed content analysis using codes developed from the TDF. RESULTS: A purposive sample of 35 health care professionals participated. Experience varied from infrequent to several years of frequent MI-E use in different patient populations. We identified four main themes: (1) knowledge; (2) beliefs; (3) clinical decision-making; and (4) future adoption. CONCLUSION: Interprofessional knowledge and expertise of MI-E in invasively ventilated patients is limited due to minimal available evidence and adoption. Participants believed MI-E a potentially useful intervention for airway clearance and inclusion in weaning protocols when more evidence is available. RELEVANCE TO CLINICAL PRACTICE: This focus group study provides an overview of current practice, knowledge and expertise, and barriers and facilitators to using MI-E in mechanically ventilated patients. From these data, it is evident there is a need to develop further clinical expertise and evidence of efficacy to further understand the role of MI-E as an airway clearance technique for ventilated patients.


Assuntos
Insuflação , Respiração Artificial , Humanos , Grupos Focais , Insuflação/métodos , Estado Terminal/terapia , Tosse
7.
J Clin Med ; 11(23)2022 11 26.
Artigo em Inglês | MEDLINE | ID: mdl-36498564

RESUMO

We describe the incidence, practice and associations with outcomes of awake prone positioning in patients with acute hypoxemic respiratory failure due to coronavirus disease 2019 (COVID-19) in a national multicenter observational cohort study performed in 16 intensive care units in the Netherlands (PRoAcT−COVID-study). Patients were categorized in two groups, based on received treatment of awake prone positioning. The primary endpoint was practice of prone positioning. Secondary endpoint was 'treatment failure', a composite of intubation for invasive ventilation and death before day 28. We used propensity matching to control for observed confounding factors. In 546 patients, awake prone positioning was used in 88 (16.1%) patients. Prone positioning started within median 1 (0 to 2) days after ICU admission, sessions summed up to median 12.0 (8.4−14.5) hours for median 1.0 day. In the unmatched analysis (HR, 1.80 (1.41−2.31); p < 0.001), but not in the matched analysis (HR, 1.17 (0.87−1.59); p = 0.30), treatment failure occurred more often in patients that received prone positioning. The findings of this study are that awake prone positioning was used in one in six COVID-19 patients. Prone positioning started early, and sessions lasted long but were often discontinued because of need for intubation.

8.
Respir Care ; 67(8): 1043-1057, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35610033

RESUMO

Mechanical insufflation-exsufflation (MI-E) is traditionally used in the neuromuscular population. There is growing interest of MI-E use in invasively ventilated critically ill adults. We aimed to map current evidence on MI-E use in invasively ventilated critically ill adults. Two authors independently searched electronic databases MEDLINE, Embase, and CINAHL via the Ovid platform; PROSPERO; Cochrane Library; ISI Web of Science; and International Clinical Trials Registry Platform between January 1990-April 2021. Inclusion criteria were (1) adult critically ill invasively ventilated subjects, (2) use of MI-E, (3) study design with original data, and (4) published from 1990 onward. Data were extracted by 2 authors independently using a bespoke extraction form. We used Mixed Methods Appraisal Tool to appraise risk of bias. Theoretical Domains Framework was used to interpret qualitative data. Of 3,090 citations identified, 28 citations were taken forward for data extraction. Main indications for MI-E use during invasive ventilation were presence of secretions and mucus plugging (13/28, 46%). Perceived contraindications related to use of high levels of positive pressure (18/28, 68%). Protocolized MI-E settings with a pressure of ±40 cm H2O were most commonly used, with detail on timing, flow, and frequency of prescription infrequently reported. Various outcomes were re-intubation rate, wet sputum weight, and pulmonary mechanics. Only 3 studies reported the occurrence of adverse events. From qualitative data, the main barrier to MI-E use in this subject group was lack of knowledge and skills. We concluded that there is little consistency in how MI-E is used and reported, and therefore, recommendations about best practices are not possible.


Assuntos
Estado Terminal , Insuflação , Adulto , Estado Terminal/terapia , Humanos , Insuflação/métodos , Pulmão , Respiração Artificial/efeitos adversos
9.
J Clin Med ; 10(20)2021 10 19.
Artigo em Inglês | MEDLINE | ID: mdl-34682907

RESUMO

We describe the incidence and practice of prone positioning and determined the association of use of prone positioning with outcomes in invasively ventilated patients with acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) in a national, multicenter observational study, performed at 22 intensive care units in the Netherlands. Patients were categorized into 4 groups, based on indication for and actual use of prone positioning. The primary outcome was 28-day mortality. Secondary endpoints were 90-day mortality, and ICU and hospital length of stay. In 734 patients, prone positioning was indicated in 60%-the incidence of prone positioning was higher in patients with an indication than in patients without an indication for prone positioning (77 vs. 48%, p = 0.001). Patients were left in the prone position for median 15.0 (10.5-21.0) hours per full calendar day-the duration was longer in patients with an indication than in patients without an indication for prone positioning (16.0 (11.0-23.0) vs. 14.0 (10.0-19.0) hours, p < 0.001). Ventilator settings and ventilation parameters were not different between the four groups, except for FiO2 which was higher in patients having an indication for and actually receiving prone positioning. Our data showed no difference in mortality at day 28 between the 4 groups (HR no indication, no prone vs. no indication, prone vs. indication, no prone vs. indication, prone: 1.05 (0.76-1.45) vs. 0.88 (0.62-1.26) vs. 1.15 (0.80-1.54) vs. 0.96 (0.73-1.26) (p = 0.08)). Factors associated with the use of prone positioning were ARDS severity and FiO2. The findings of this study are that prone positioning is often used in COVID-19 patients, even in patients that have no indication for this intervention. Sessions of prone positioning lasted long. Use of prone positioning may affect outcomes.

10.
J Clin Med ; 10(15)2021 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-34362165

RESUMO

Airway care interventions may prevent accumulation of airway secretions and promote their evacuation, but evidence is scarce. Interventions include heated humidification, nebulization of mucolytics and/or bronchodilators, manual hyperinflation and use of mechanical insufflation-exsufflation (MI-E). Our aim is to identify current airway care practices for invasively ventilated patients in intensive care units (ICU) in the Netherlands. A self-administered web-based survey was sent to a single pre-appointed representative of all ICUs in the Netherlands. Response rate was 85% (72 ICUs). We found substantial heterogeneity in the intensity and combinations of airway care interventions used. Most (81%) ICUs reported using heated humidification as a routine prophylactic intervention. All (100%) responding ICUs used nebulized mucolytics and/or bronchodilators; however, only 43% ICUs reported nebulization as a routine prophylactic intervention. Most (81%) ICUs used manual hyperinflation, although only initiated with a clinical indication like difficult oxygenation. Few (22%) ICUs used MI-E for invasively ventilated patients. Use was always based on the indication of insufficient cough strength or as a continuation of home use. In the Netherlands, use of routine prophylactic airway care interventions is common despite evidence of no benefit. There is an urgent need for evidence of the benefit of these interventions to inform evidence-based guidelines.

11.
Ann Transl Med ; 9(9): 813, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-34268426

RESUMO

BACKGROUND: Patients with coronavirus disease 2019 (COVID-19) may need hospitalization for supplemental oxygen, and some need intensive care unit (ICU) admission for escalation of care. Practice of adjunctive and supportive treatments remain uncertain and may vary widely between countries, within countries between hospitals, and possibly even within ICUs. We aim to investigate practice of adjunctive and supportive treatments, and their associations with outcome, in critically ill COVID-19 patients. METHODS: The 'PRactice of Adjunctive Treatments in Intensive Care Unit Patients with Coronavirus Disease 2019' (PRoAcT-COVID) study is a national, observational study to be undertaken in a large set of ICUs in The Netherlands. The PRoAcT-COVID includes consecutive ICU patients, admitted because of COVID-19 to one of the participating ICUs during a 3-month period. Daily follow-up lasts 28 days. The primary endpoint is a combination of adjunctive treatments, including types of oxygen support, ventilation, rescue therapies for hypoxemia refractory to supplementary oxygen or during invasive ventilation, other adjunctive and supportive treatments, and experimental therapies. We will also collect tracheostomy rate, duration of invasive ventilation and ventilator-free days and alive at day 28 (VFD-28), ICU and hospital length of stay, and the mortality rates in the ICU, hospital and at day 90. DISCUSSION: The PRoAcT-COVID study is an observational study combining high density treatment data with relevant clinical outcomes. Information on treatment practices, and their associations with outcomes in COVID-19 patients in highly and urgently needed. The results of the PRoAcT-COVID study will be rapidly available, and circulated through online presentations, such as webinars and electronic conferences, and publications in peer-reviewed journals-findings will also be presented at a dedicated website. At request, and after agreement of the PRoAcT-COVID steering committee, source data will be made available through local, regional and national anonymized datasets. TRIAL REGISTRATION: The PRoAcT-COVID study is registered at clinicaltrials.gov (study identifier NCT04719182).

12.
Am J Trop Med Hyg ; 104(5): 1676-1686, 2021 Mar 11.
Artigo em Inglês | MEDLINE | ID: mdl-33705348

RESUMO

Non-intubated patients with acute respiratory failure due to COVID-19 could benefit from awake proning. Awake proning is an attractive intervention in settings with limited resources, as it comes with no additional costs. However, awake proning remains poorly used probably because of unfamiliarity and uncertainties regarding potential benefits and practical application. To summarize evidence for benefit and to develop a set of pragmatic recommendations for awake proning in patients with COVID-19 pneumonia, focusing on settings where resources are limited, international healthcare professionals from high and low- and middle-income countries (LMICs) with known expertise in awake proning were invited to contribute expert advice. A growing number of observational studies describe the effects of awake proning in patients with COVID-19 pneumonia in whom hypoxemia is refractory to simple measures of supplementary oxygen. Awake proning improves oxygenation in most patients, usually within minutes, and reduces dyspnea and work of breathing. The effects are maintained for up to 1 hour after turning back to supine, and mostly disappear after 6-12 hours. In available studies, awake proning was not associated with a reduction in the rate of intubation for invasive ventilation. Awake proning comes with little complications if properly implemented and monitored. Pragmatic recommendations including indications and contraindications were formulated and adjusted for resource-limited settings. Awake proning, an adjunctive treatment for hypoxemia refractory to supplemental oxygen, seems safe in non-intubated patients with COVID-19 acute respiratory failure. We provide pragmatic recommendations including indications and contraindications for the use of awake proning in LMICs.


Assuntos
COVID-19/complicações , Hipóxia/terapia , Decúbito Ventral/fisiologia , Insuficiência Respiratória/terapia , SARS-CoV-2 , Doença Aguda , Pressão Positiva Contínua nas Vias Aéreas , Pessoal de Saúde , Humanos , Vigília
13.
Syst Rev ; 9(1): 287, 2020 12 08.
Artigo em Inglês | MEDLINE | ID: mdl-33292485

RESUMO

BACKGROUND: Critically ill patients receiving invasive ventilation are at risk of sputum retention. Mechanical insufflation-exsufflation (MI-E) is a technique used to mobilise sputum and optimise airway clearance. Recently, interest has increased in the use of mechanical insufflation-exsufflation for invasively ventilated critically ill adults, but evidence for the feasibility, safety and efficacy of this treatment is sparse. The aim of this scoping review is to map current and emerging evidence on the feasibility, safety and efficacy of MI-E for invasively ventilated adult patients with the aim of highlighting knowledge gaps and identifying areas for future research. Specific research questions aim to identify information informing indications and contraindications to the use of MI-E in the invasively ventilated adult, MI-E settings used, outcome measures reported within studies, adverse effects reported and perceived barriers and facilitators to using MI-E reported. METHODS: We will search electronic databases MEDLINE, EMBASE, CINAHL using the OVID platform, PROSPERO, The Cochrane Library, ISI Web of Science and the International Clinical Trials Registry Platform. Two authors will independently screen citations, extract data and evaluate risk of bias using the Mixed Methods Appraisal Tool. Studies included will present original data and describe MI-E in invasively ventilated adult patients from 1990 onwards. Our exclusion criteria are studies in a paediatric population, editorial pieces or letters and animal or bench studies. Search results will be presented in a PRISMA study flow diagram. Descriptive statistics will be used to summarise quantitative data. For qualitative data relating to barriers and facilitators, we will use content analysis and the Theoretical Domains Framework (TDF) as a conceptual framework. Additional tables and relevant figures will present data addressing our research questions. DISCUSSION: Our findings will enable us to map current and emerging evidence on the feasibility, safety and efficacy of MI-E for invasively ventilated critically ill adult patients. These data will provide description of how the technique is currently used, support healthcare professionals in their clinical decision making and highlight areas for future research in this important clinical area. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework submitted on 9 July 2020.  https://osf.io/mpksq/ .


Assuntos
Estado Terminal , Insuflação , Adulto , Criança , Tosse , Humanos , Pulmão , Respiração Artificial , Literatura de Revisão como Assunto , Revisões Sistemáticas como Assunto
14.
J Crit Care ; 56: 1-5, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31765909

RESUMO

PURPOSE: Half of the patients experience pain during their ICU stay which is known to influence their outcomes. Nurses and physicians encounter organizational barriers towards pain assessment and treatment. We aimed to evaluate the association between adequate pain management and nurse to patient ratio, bed occupancy rate, and fulltime presence of an intensivist. MATERIALS AND METHODS: We performed unadjusted and case-mix adjusted mixed-effect logistic regression modeling on data from thirteen Dutch ICUs to investigate the association between ICU organizational characteristics and adequate pain management, i.e. patient-shift observations in which patients' pain was measured and acceptable, or unacceptable and normalized within 1 h. All ICU patients admitted between December 2017 and June 2018 were included, excluding patients who were delirious, comatose or had a Glasgow coma score < 8 at the first day of ICU admission. RESULTS: Case-mix adjusted nurse to patient ratios of 0.70 to 0.80 and over 0.80 were significantly associated with adequate pain management (OR [95% confidence interval] of respectively 1.14 [1.07-1.21] and 1.16 [1.08-1.24]). Bed occupancy rate and intensivist presence showed no association. CONCLUSION: Higher nurse to patient ratios increase the percentage of patients with adequate pain management especially in medical and mechanically ventilated patients.


Assuntos
Ocupação de Leitos , Cuidados Críticos/organização & administração , Mão de Obra em Saúde , Unidades de Terapia Intensiva/organização & administração , Manejo da Dor/métodos , Idoso , Feminino , Mortalidade Hospitalar , Hospitalização , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Países Baixos , Enfermeiras e Enfermeiros , Médicos , Análise de Regressão , Respiração Artificial/métodos
15.
Nurs Crit Care ; 24(3): 132-140, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-26689613

RESUMO

BACKGROUND: Systematic assessment of pain is necessary for adequate treatment of pain. Patient self-reported pain is a superior assessment but is of limited use for intubated patients in the intensive care unit. For these patients, the critical-care pain observation tool (CPOT) has been developed. AIM: To perform a validation of the Dutch CPOT. STUDY DESIGN: Cross-sectional observational study. METHODS: The Dutch translation of the CPOT was used. Clinimetric characteristics were analysed in a cross-sectional design. Internal consistency (Cronbach's alpha) was tested by collecting CPOT scores in patients at rest and during turning. Inter-rater reliability was tested by collecting CPOT scores simultaneously by two different nurses who were blinded to each other's scores. Criterion validity (area under the curve, sensitivity and specificity) of the Dutch CPOT (index test) was analysed using patient self-reported pain (reference test). RESULTS: Cronbach's alpha was 0.56. During rest, the inter-rater reliability was 0.38 (95% confidence interval (CI): 0.20-0.53). During turning, the inter-rater reliability was 0.56 (95% CI: 0.42-0.68; area under the curve = 0.65 [95% CI 0.57-0.73]). At a threshold CPOT score of 2, the sensitivity and specificity were 39% and 85%, respectively. CONCLUSION: The Dutch CPOT is available for pain assessment in intubated patients unable to self-report. Inter-rater reliability is moderate. At the threshold, a CPOT score of 2, the sensitivity was 39% and the specificity of 85%. RELEVANCE TO CLINICAL PRACTICE: The CPOT is easy to use for systematic assessment of pain. Additional information about the threshold is valuable for use in daily practice.


Assuntos
Cuidados Críticos , Unidades de Terapia Intensiva , Medição da Dor , Idoso , Estudos Transversais , Feminino , Humanos , Masculino , Países Baixos , Reprodutibilidade dos Testes , Tradução
16.
JAMA ; 319(10): 993-1001, 2018 03 13.
Artigo em Inglês | MEDLINE | ID: mdl-29486489

RESUMO

Importance: It remains uncertain whether nebulization of mucolytics with bronchodilators should be applied for clinical indication or preventively in intensive care unit (ICU) patients receiving invasive ventilation. Objective: To determine if a strategy that uses nebulization for clinical indication (on-demand) is noninferior to one that uses preventive (routine) nebulization. Design, Setting, and Participants: Randomized clinical trial enrolling adult patients expected to need invasive ventilation for more than 24 hours at 7 ICUs in the Netherlands. Interventions: On-demand nebulization of acetylcysteine or salbutamol (based on strict clinical indications, n = 471) or routine nebulization of acetylcysteine with salbutamol (every 6 hours until end of invasive ventilation, n = 473). Main Outcomes and Measures: The primary outcome was the number of ventilator-free days at day 28, with a noninferiority margin for a difference between groups of -0.5 days. Secondary outcomes included length of stay, mortality rates, occurrence of pulmonary complications, and adverse events. Results: Nine hundred twenty-two patients (34% women; median age, 66 (interquartile range [IQR], 54-75 years) were enrolled and completed follow-up. At 28 days, patients in the on-demand group had a median 21 (IQR, 0-26) ventilator-free days, and patients in the routine group had a median 20 (IQR, 0-26) ventilator-free days (1-sided 95% CI, -0.00003 to ∞). There was no significant difference in length of stay or mortality, or in the proportion of patients developing pulmonary complications, between the 2 groups. Adverse events (13.8% vs 29.3%; difference, -15.5% [95% CI, -20.7% to -10.3%]; P < .001) were more frequent with routine nebulization and mainly related to tachyarrhythmia (12.5% vs 25.9%; difference, -13.4% [95% CI, -18.4% to -8.4%]; P < .001) and agitation (0.2% vs 4.3%; difference, -4.1% [95% CI, -5.9% to -2.2%]; P < .001). Conclusions and Relevance: Among ICU patients receiving invasive ventilation who were expected to not be extubated within 24 hours, on-demand compared with routine nebulization of acetylcysteine with salbutamol did not result in an inferior number of ventilator-free days. On-demand nebulization may be a reasonable alternative to routine nebulization. Trial Registration: clinicaltrials.gov Identifier: NCT02159196.


Assuntos
Acetilcisteína/administração & dosagem , Albuterol/administração & dosagem , Cuidados Críticos , Nebulizadores e Vaporizadores , Respiração Artificial , Administração por Inalação , Adulto , Idoso , Feminino , Humanos , Unidades de Terapia Intensiva , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Desmame do Respirador
18.
J Cardiothorac Vasc Anesth ; 31(4): 1227-1234, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28800982

RESUMO

OBJECTIVES: The Behavioral Pain Scale (BPS) and Critical-Care Pain Observation Tool (CPOT) are behavioral pain assessment tools for sedated and unconscious critically ill patients. The aim of this study was to compare the reliability, internal consistency, and discriminant validation of the BPS and the CPOT simultaneously in mechanically ventilated patients after cardiac surgery. DESIGN: A prospective, observational cohort study. SETTING: A 20-bed closed-format intensive care unit with mixed medical, surgical, and cardiac surgery patients in a teaching hospital in Amsterdam, The Netherlands. PARTICIPANTS: The study comprised 72 consecutive intubated and mechanically ventilated patients after cardiac surgery who were not able to self-report pain. MEASUREMENTS AND MAIN RESULTS: Two nurses assessed the BPS and CPOT simultaneously and independently at the following 4 moments: rest, a nonpainful procedure (oral care), rest, and a painful procedure (turning). Both scores showed a significant increase of 2 points between rest and turning. The median BPS score of nurse 1 showed a significant increase of 1 point between rest and the nonpainful procedure (oral care), whereas both median CPOT scores did not change. The interrater reliability of the BPS and CPOT showed fair-to-good agreement of 0.74 overall. During the periods of rest 1 and rest 2, values ranged from 0.24 to 0.46. Cronbach's alpha values for the BPS were 0.62 (nurse 1) and 0.59 (nurse 2) compared with 0.65 and 0.58, respectively, for the CPOT. CONCLUSIONS: The BPS and CPOT are reliable and valid pain assessment tools in a daily clinical setting. However, the discriminant validation of both scores seems less satisfactory in sedated or agitated patients and this topic requires further investigation.


Assuntos
Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Cuidados Críticos/normas , Medição da Dor/normas , Dor Pós-Operatória/diagnóstico , Respiração Artificial/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos Cardíacos/psicologia , Procedimentos Cirúrgicos Cardíacos/tendências , Estudos de Coortes , Cuidados Críticos/métodos , Cuidados Críticos/psicologia , Estado Terminal/terapia , Feminino , Humanos , Unidades de Terapia Intensiva/normas , Masculino , Pessoa de Meia-Idade , Medição da Dor/métodos , Medição da Dor/psicologia , Dor Pós-Operatória/psicologia , Estudos Prospectivos , Respiração Artificial/psicologia , Respiração Artificial/tendências
19.
Trials ; 16: 389, 2015 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-26329352

RESUMO

BACKGROUND: Preventive nebulization of mucolytic agents and bronchodilating drugs is a strategy aimed at the prevention of sputum plugging, and therefore atelectasis and pneumonia, in intubated and ventilated intensive care unit (ICU) patients. The present trial aims to compare a strategy using the preventive nebulization of acetylcysteine and salbutamol with nebulization on indication in intubated and ventilated ICU patients. METHODS/DESIGN: The preventive nebulization of mucolytic agents and bronchodilating drugs in invasively ventilated intensive care unit patients (NEBULAE) trial is a national multicenter open-label, two-armed, randomized controlled non-inferiority trial in the Netherlands. Nine hundred and fifty intubated and ventilated ICU patients with an anticipated duration of invasive ventilation of more than 24 hours will be randomly assigned to receive either a strategy consisting of preventive nebulization of acetylcysteine and salbutamol or a strategy consisting of nebulization of acetylcysteine and/or salbutamol on indication. The primary endpoint is the number of ventilator-free days and surviving on day 28. Secondary endpoints include ICU and hospital length of stay, ICU and hospital mortality, the occurrence of predefined pulmonary complications (acute respiratory distress syndrome, pneumonia, large atelectasis and pneumothorax), and the occurrence of predefined side effects of the intervention. Related healthcare costs will be estimated in a cost-benefit and budget-impact analysis. DISCUSSION: The NEBULAE trial is the first randomized controlled trial powered to investigate whether preventive nebulization of acetylcysteine and salbutamol shortens the duration of ventilation in critically ill patients. TRIAL REGISTRATION: NCT02159196, registered on 6 June 2014.


Assuntos
Acetilcisteína/administração & dosagem , Albuterol/administração & dosagem , Broncodilatadores/administração & dosagem , Expectorantes/administração & dosagem , Unidades de Terapia Intensiva , Respiração Artificial , Acetilcisteína/efeitos adversos , Acetilcisteína/economia , Administração por Inalação , Albuterol/efeitos adversos , Albuterol/economia , Broncodilatadores/efeitos adversos , Broncodilatadores/economia , Protocolos Clínicos , Análise Custo-Benefício , Estado Terminal , Esquema de Medicação , Custos de Medicamentos , Quimioterapia Combinada , Expectorantes/efeitos adversos , Expectorantes/economia , Mortalidade Hospitalar , Humanos , Unidades de Terapia Intensiva/economia , Tempo de Internação , Nebulizadores e Vaporizadores , Países Baixos , Pneumonia Associada à Ventilação Mecânica/etiologia , Pneumonia Associada à Ventilação Mecânica/prevenção & controle , Atelectasia Pulmonar/etiologia , Atelectasia Pulmonar/prevenção & controle , Projetos de Pesquisa , Respiração Artificial/efeitos adversos , Respiração Artificial/economia , Fatores de Tempo , Resultado do Tratamento
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