Lung Volume Preservation During Extubation

NCT05526053 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1753

Last updated 2025-12-22

No results posted yet for this study

Summary

Introduction: At present, the best spontaneous breathing trial (SBT) during weaning from mechanical ventilation is a 30-min test with pressure support (PSV) 8 cmH2O without positive end-expiratory pressure (PEEP). There is a debate about the possible collapse of some alveolar units during such SBT and during extubation with continuous suctioning. A few experiences show extubation without suctioning as feasible and safe. Lung ultrasound is a non invasive and useful exploration tool to assess the lung aeration.

Hypothesis: Techniques aimed at preserving lung volume during SBT and extubation can yield higher rates of successful extubation. The preserved lung volume of each SBT and extubation strategy can be assessed by using lung ultrasound.

Primary objective: To define the rates of successful extubation in two extubation approaches aiming at different levels of lung volume preservation: standard SBT (30-min PSV 8 cmH2O without PEEP followed by extubation with continuous suctioning) versus experimental SBT (PSV8+ PEEP 5 cmH2O followed by extubation without suctioning). To define the lung aeration levels using the modified Lung Ultrasound Score (LUS) of each SBT strategy.

Secondary objectives: Reintubation rate, ICU and hospital stays, and mortality in each group. To define the diaphragm and intercostal thickness and thickening fraction in different levels of lung volume preservation.

Design: Prospective, multicenter, randomized study. Two opposing extubation strategies are compared in randomly assigned patients.The level of aeration is assessed using lung ultrasound.

Conditions

  • Weaning Failure
  • Pulmonary Collapse

Interventions

OTHER

Lung volume preservation

Extubate the patient connected to the ventilator and PEEP of 5 cmH2O after a successful SBT also using PEEP.

Sponsors & Collaborators

  • Althaia Xarxa Assistencial Universitària de Manresa

    lead OTHER

Principal Investigators

  • Rafael Fernandez, PhD · Althaia Xarxa Assistencial de Manresa

  • Carlos Subira, PhD · Althaia Xarxa Assitencial de Manresa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2024-08-13
Completion
2024-08-13

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05526053 on ClinicalTrials.gov