Effect of lung volume preservation during spontaneous breathing trial on successful extubation in patients receiving mechanical ventilation: protocol for a multicenter clinical trial.

Humans Ventilator Weaning / methods Airway Extubation Multicenter Studies as Topic Positive-Pressure Respiration / methods Lung / physiopathology Lung Volume Measurements Ultrasonography Treatment Outcome Male Time Factors Female Adult Middle Aged Respiration, Artificial / methods Randomized Controlled Trials as Topic Aged Suction / methods Equivalence Trials as Topic

Extubation Lung ultrasound Mechanical ventilation Spontaneous breathing trial Weaning

Journal

Trials

ISSN: 1745-6215

Titre abrégé: Trials

Pays: England

ID NLM: 101263253

Informations de publication

Date de publication:
16 Jul 2024

Historique:

received: 09 01 2024

accepted: 27 06 2024

medline: 17 7 2024

pubmed: 17 7 2024

entrez: 16 7 2024

Statut: epublish

Résumé

In standard weaning from mechanical ventilation, a successful spontaneous breathing test (SBT) consisting of 30 min 8 cmH This multicenter superiority trial will randomly assign eligible patients to receive either standard weaning [SBT: 30-min PSV8 without PEEP followed by extubation with continuous suctioning] or lung-volume-preservation weaning [SBT: 30-min PSV8 + 5 cmH We aim to recruit a large sample of representative patients (N = 1600). Our study cannot elucidate the specific effects of PEEP during SBT and of positive pressure during extubation; the results will show the joint effects derived from the synergy of these two factors. Although universal ultrasound monitoring of lungs, diaphragm, and intercostal muscles throughout weaning is unfeasible, if derecruitment is a major cause of weaning failure, ultrasound may help clinicians decide about extubation in high-risk and borderline patients. The Research Ethics Committee (CEIm) of the Fundació Unió Catalana d'Hospitals approved the study (CEI 22/67 and 23/26). Registered at ClinicalTrials.gov in August 2023. Identifier: NCT05526053.

Sections du résumé

BACKGROUND BACKGROUND

In standard weaning from mechanical ventilation, a successful spontaneous breathing test (SBT) consisting of 30 min 8 cmH

METHODS METHODS

This multicenter superiority trial will randomly assign eligible patients to receive either standard weaning [SBT: 30-min PSV8 without PEEP followed by extubation with continuous suctioning] or lung-volume-preservation weaning [SBT: 30-min PSV8 + 5 cmH

DISCUSSION CONCLUSIONS

We aim to recruit a large sample of representative patients (N = 1600). Our study cannot elucidate the specific effects of PEEP during SBT and of positive pressure during extubation; the results will show the joint effects derived from the synergy of these two factors. Although universal ultrasound monitoring of lungs, diaphragm, and intercostal muscles throughout weaning is unfeasible, if derecruitment is a major cause of weaning failure, ultrasound may help clinicians decide about extubation in high-risk and borderline patients.

TRIAL REGISTRATION BACKGROUND

The Research Ethics Committee (CEIm) of the Fundació Unió Catalana d'Hospitals approved the study (CEI 22/67 and 23/26). Registered at ClinicalTrials.gov in August 2023. Identifier: NCT05526053.

Identifiants

DOI: 10.1186/s13063-024-08297-1 PMID: 39014430

pubmed: 39014430

doi: 10.1186/s13063-024-08297-1

pii: 10.1186/s13063-024-08297-1

doi:

Banques de données

ClinicalTrials.gov

['NCT05526053']

Types de publication

Journal Article Clinical Trial Protocol

Langues

eng

Sous-ensembles de citation

Pagination

481

Subventions

Organisme : Fundacion Española del Enfermo Crítico

ID : FEEC2022/002

Informations de copyright

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