Evidence map›Paper›PMID 26329352›Full record

Trial reportTrials2015

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

Sophia M van der Hoeven, Jan M Binnekade, Corianne A J M de Borgie, Frank H Bosch, Henrik Endeman, Janneke Horn, Nicole P Juffermans, Nardo J M van der Meer, Maruschka P Merkus, Hazra S Moeniralam and 6 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02159196 (Effectiveness of Routine Nebulization of Mucolytics and Bronchodilators in Mechanically Ventilated Intensive Care Patients'), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02159196 nacompletednot on this map

Effectiveness of Routine Nebulization of Mucolytics and Bronchodilators in Mechanically Ventilated Intensive Care Patients'

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2014 to 2017Enrolled950ConditionsRespiratory FailureArmsacetylcysteine and salbutamol, acetylcysteine, salbutamol
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 1 country.

Sophia M van der HoevenDepartment of Intensive Care, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. s.m.vanderhoeven@amc.uva.nl.
Jan M BinnekadeDepartment of Intensive Care, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. j.m.binnekade@amc.uva.nl.
Corianne A J M de BorgieClinical Research Unit, Amsterdam, The Netherlands. c.deborgie@amc.uva.nl.
Frank H BoschDepartment of Intensive Care, Rijnstate, Arnhem, The Netherlands. FHBosch@rijnstate.nl.
Henrik EndemanDepartment of Intensive Care, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. H.Endeman@olvg.nl.
Janneke HornDepartment of Intensive Care, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. j.horn@amc.uva.nl.
Nicole P JuffermansDepartment of Intensive Care, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. n.p.juffermans@amc.uva.nl.
Nardo J M van der MeerDepartment of Intensive Care, Amphia Hospital, Breda, Oosterhout and Etten-Leur, The Netherlands. bvandermeer@amphia.nl.
Maruschka P MerkusClinical Research Unit, Amsterdam, The Netherlands. m.merkus@amc.uva.nl.
Hazra S MoeniralamDepartment of Intensive Care, Antonius Hospital, Nieuwegein, The Netherlands. h.moeniralam@antoniusziekenhuis.nl.
Bart van SilfhoutDepartment of Intensive Care, Antonius Hospital, Nieuwegein, The Netherlands. bartsilfhout@antoniusziekenhuis.nl.
Mathilde SlabbekoornDepartment of Intensive Care, Medical Center Haaglanden and Leidschendam, The Hague, The Netherlands. m.slabbekoorn@mchaaglanden.nl.
Willemke StilmaDepartment of Intensive Care, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. W.Stilma@olvg.nl.
Jan Willem WijnhovenDepartment of Intensive Care, Amphia Hospital, Breda, Oosterhout and Etten-Leur, The Netherlands. JWijnhoven@Amphia.nl.
Marcus J SchultzDepartment of Intensive Care, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. marcus.j.schultz@gmail.com.
Frederique PaulusDepartment of Intensive Care, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. f.paulus@amc.uva.nl.
Amsterdam UMC Location University of Amsterdam · NLOLVG · NLSt. Antonius Ziekenhuis · NLAmphia Ziekenhuis · NLGGD Haaglanden · NLMerus (Netherlands) · NLRijnstate Hospital · NLTilburg University · NLUniversity of Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreventive 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/

designThe 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 registrationNCT02159196, registered on 6 June 2014.

Indexed as

Intensive Care UnitsRespiration, ArtificialAcetylcysteineAdministration, InhalationAlbuterolBronchodilator AgentsClinical ProtocolsCost-Benefit AnalysisCritical IllnessDrug Administration ScheduleDrug CostsDrug Therapy, CombinationExpectorantsHospital MortalityHumansLength of StayAcetylcysteineAlbuterolBronchodilator AgentsExpectorants

Identifiers

PMID26329352
PMCPMC4557315
OpenAlexW1957727215

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.