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Preventive nebulization of mucolytic agents and bronchodilating drugs in invasively ventilated intensive care unit patients (NEBULAE): study protocol for a randomized controlled trial.

ABSTRACT: 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.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.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.NCT02159196, registered on 6 June 2014.

SUBMITTER: van der Hoeven SM

PROVIDER: S-EPMC4557315 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Preventive nebulization of mucolytic agents and bronchodilating drugs in invasively ventilated intensive care unit patients (NEBULAE): study protocol for a randomized controlled trial.

van der Hoeven Sophia M SM Binnekade Jan M JM de Borgie Corianne A J M CA Bosch Frank H FH Endeman Henrik H Horn Janneke J Juffermans Nicole P NP van der Meer Nardo J M NJ Merkus Maruschka P MP Moeniralam Hazra S HS van Silfhout Bart B Slabbekoorn Mathilde M Stilma Willemke W Wijnhoven Jan Willem JW Schultz Marcus J MJ Paulus Frederique F

Trials 20150902

<h4>Background</h4>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.<h4>Methods/design</h4>The preventive nebulization of mucolytic ...[more]

PMID: 26329352

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Project description:BackgroundGeoeconomic variations in epidemiology, the practice of ventilation, and outcome in invasively ventilated intensive care unit (ICU) patients without acute respiratory distress syndrome (ARDS) remain unexplored. In this analysis we aim to address these gaps using individual patient data of four large observational studies.MethodsIn this pooled analysis we harmonised individual patient data from the ERICC, LUNG SAFE, PRoVENT, and PRoVENT-iMiC prospective observational studies, which were conducted from June, 2011, to December, 2018, in 534 ICUs in 54 countries. We used the 2016 World Bank classification to define two geoeconomic regions: middle-income countries (MICs) and high-income countries (HICs). ARDS was defined according to the Berlin criteria. Descriptive statistics were used to compare patients in MICs versus HICs. The primary outcome was the use of low tidal volume ventilation (LTVV) for the first 3 days of mechanical ventilation. Secondary outcomes were key ventilation parameters (tidal volume size, positive end-expiratory pressure, fraction of inspired oxygen, peak pressure, plateau pressure, driving pressure, and respiratory rate), patient characteristics, the risk for and actual development of acute respiratory distress syndrome after the first day of ventilation, duration of ventilation, ICU length of stay, and ICU mortality.FindingsOf the 7608 patients included in the original studies, this analysis included 3852 patients without ARDS, of whom 2345 were from MICs and 1507 were from HICs. Patients in MICs were younger, shorter and with a slightly lower body-mass index, more often had diabetes and active cancer, but less often chronic obstructive pulmonary disease and heart failure than patients from HICs. Sequential organ failure assessment scores were similar in MICs and HICs. Use of LTVV in MICs and HICs was comparable (42·4% vs 44·2%; absolute difference -1·69 [-9·58 to 6·11] p=0·67; data available in 3174 [82%] of 3852 patients). The median applied positive end expiratory pressure was lower in MICs than in HICs (5 [IQR 5-8] vs 6 [5-8] cm H2O; p=0·0011). ICU mortality was higher in MICs than in HICs (30·5% vs 19·9%; p=0·0004; adjusted effect 16·41% [95% CI 9·52-23·52]; p<0·0001) and was inversely associated with gross domestic product (adjusted odds ratio for a US$10 000 increase per capita 0·80 [95% CI 0·75-0·86]; p<0·0001).InterpretationDespite similar disease severity and ventilation management, ICU mortality in patients without ARDS is higher in MICs than in HICs, with a strong association with country-level economic status.FundingNo funding.

Project description:INTRODUCTION:The Chinese herb da huang (DH) (Rhubarb) is commonly used for GIF intensive care unit (ICU)/pediatric intensive care unit (PICU) gastrointestinal failure (GIF) patients in China. However, the potential preventive and therapeutic effect of DH in these patients has not yet been studied systematically. OBJECTIVES:The aim of this study was to evaluate the preventive and therapeutic effects of DH in treating ICU/PICU GIF patients with the most recent evidence. METHODS:We systematically searched 7 databases from inception to March 30, 2018. RevMan 5.3 software was used to perform a meta-analysis. GRADE methodology was applied to evaluate the quality of evidence for each outcome. The review protocol was registered on PROSPERO (CRD42018092710) in advance. RESULTS:Seven studies comprising 788 pediatric or adult participants were included in this analysis. Three indicators, including GIF occurrence rates (gastrointestinal mucosal hemorrhage, enteroplegia), multiple organ dysfunction syndrome (MODS)-related items (occurrence rates of MODS, mortality rates of MODS) and duration in the ICU was analyzed. The GIF occurrence rate meta-analysis result was (RR 0.47, CI 95% 0.37-0.60; P = .95); MODS related items indicator result was (RR 0.44, CI 95% 0.33-0.59; P = .41); ICU duration ICU result was (RR -2.87, CI 95% -3.53--2.21; P = .40). The safety of Chinese herb DH (Rhubarb) remains unclear. CONCLUSION:Current evidence suggests that the Chinese herb rhubarb (DH) powder combined with Western medicine was inferior to Western medicine alone in terms of preventive and therapeutic effects in ICU/PICU patients in terms of decreasing GIF occurrence rates (gastrointestinal mucosal hemorrhage and enteroplegia), occurrence rates of MODS, mortality from MODS, and shortened duration time in the ICU/PICU. However, larger sample sizes and rigorously-designed studies are necessary to conclusively determine the association between DH powder and outcomes in ICU/PICU GIF patients.

Project description:BackgroundCritically 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.MethodsWe 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.DiscussionOur 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 registrationOpen Science Framework submitted on 9 July 2020. https://osf.io/mpksq/ .

Dataset Information

Preventive nebulization of mucolytic agents and bronchodilating drugs in invasively ventilated intensive care unit patients (NEBULAE): study protocol for a randomized controlled trial.

Publications

Preventive nebulization of mucolytic agents and bronchodilating drugs in invasively ventilated intensive care unit patients (NEBULAE): study protocol for a randomized controlled trial.

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