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Trial of Spontaneous Breathing Test

NCT06593288 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2024-12-06

No results posted yet for this study

Summary

The hypothesis is that the Spontaneous Breathing Test (SBT) without pressure support (PS) is not inferior to the SBT with pressure support in relation to the following outcomes: a) extubation failure; b) time on MV.

The main objective of this study is to determine whether SBT without PS is non-inferior to SBT with PS in relation to the primary outcome: a) extubation failure; and secondary outcomes: b) length of stay in the PICU and c) days free of MV.

Pacients will be randomized to 2 arms:

1. SBT with PS
2. SBT without PS (with PEEP only)

Conditions

  • Mechanical Ventilation
  • Spontaneous Breathing Trial
  • Extubation Readiness
  • Extubation Failures
  • Pediatrics

Interventions

OTHER

Pressure Support Ventilation

Conduct the Spontaneous breathing trial with pressure support

OTHER

continuous positive airway pressure (CPAP)

Conduct the spontaneous breathing trial with CPAP

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Ana Paula C Carlotti, MD, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-10
Primary Completion
2025-12-30
Completion
2026-04-30

Countries

  • Brazil

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 NCT06593288 on ClinicalTrials.gov