Trial of Spontaneous Breathing Test

NCT06593288 | Not Yet Recruiting

• 1 other identifier: 82637424.6.1001.5440
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

spontaneous breathing trial; extubation readiness test; mechanical ventilation; pediatric intensive care

Outcome Measures

Primary Outcomes (1)

• Extubation failure

  Extubation failure: patient needs to be reintubated less than 48 hours after extubation

  48 hours

Secondary Outcomes (1)

• Free days of mechanical ventilation

  30 days

Study Arms (2)

Spontaneous breathing trial with pressure support

ACTIVE COMPARATOR

Spontaneous breathing trial with pressure support

Other: Pressure Support Ventilation

Spontaneous breathing trial without pressure support

ACTIVE COMPARATOR

Spontaneous breathing trial without pressure support ( CPAP)

Other: continuous positive airway pressure (CPAP)

Interventions

Pressure Support Ventilation OTHER

Conduct the Spontaneous breathing trial with pressure support

Spontaneous breathing trial with pressure support

continuous positive airway pressure (CPAP) OTHER

Conduct the spontaneous breathing trial with CPAP

Spontaneous breathing trial without pressure support

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients admitted to the PICU on MV for more than 24 hours
• Patients over 1 month old (corrected gestational age \> 38 weeks) and \< 18 years old on the day of screening for ERT

You may not qualify if:

• Perinatal-related lung disease
• Congenital diaphragmatic hernia or congenital/acquired paralysis of the diaphragm
• Children with heart disease
• Primary pulmonary hypertension
• Bronchiolitis obliterans
• Post-lung transplantation
• Home ventilator dependence with baseline Oxygen Saturation Index (OSI) \>6 (baseline is defined as a stable period prior to the present illness)
• Neuromuscular respiratory failure
• Critical airway obstruction (e.g., post-laryngotracheal surgery or new tracheostomy) or anatomical lower airway obstruction (e.g., mediastinal mass)
• Facial surgery or trauma in the past two weeks
• Intracranial bleeding
• Morbid obesity (2w-24mo: WHO weight-for-length z-score/height z-score ≥+3; ≥2y: WHO body mass index (BMI)-for-age z-score ≥+3)
• Family/medical team unsupportive total (patient treatment considered futile)
• Previously enrolled in a current study
• Enrolled in any other clinical trial with intervention not approved for concomitant enrollment

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

Ribeirão Preto, São Paulo, 14015-010, Brazil

Location

Related Publications (1)

• Colleti Junior J, Araujo OR, Weber KT, Santos GMVD, Silva DCBD, Volpon LC, Carlotti APCP. Protocol for a non-inferiority randomized controlled trial of spontaneous breathing trial in children with and without pressure support. Crit Care Sci. 2025 Dec 15;37:e20250187. doi: 10.62675/2965-2774.20250187. eCollection 2025.

  PMID: 41417398 DERIVED

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ana Paula C Carlotti, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José Colleti Junior, MD, PhD

CONTACT

+5511942683834; colleti@gmail.com

Ana Paula C Carlotti, MD, PhD

CONTACT

+5516997045414; apcarlotti@fmrp.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Medicine of Ribeirao Preto, University of Sao Paulo

Model Details: Randomized clinical trial with 2 arms

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: March 10, 2025
• Primary Completion: December 30, 2025
• Study Completion: April 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)