Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial (SBT-ICU)

Impact of the Combination of Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial Versus T-piece on the Time to Successful Extubation

The aim of this study is to assess if a bundle associating pressure support and positive end-expiratory pressure during spontaneous breathing trial and detection by T-piece of patients with high-risk of extubation failure can reduce the time to successful extubation in critically ill patients.

Study Overview

• Status: Completed
• Conditions: Critically Ill Adult Patients With Difficult Weaning
• Intervention / Treatment: Procedure: Assisted strategy; Procedure: Non assisted strategy

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mehdi MEZIDI, MD, PhD; Phone Number: +33 04.26.10.92.64; Email: mezidi.mehdi@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69317
    • Hopital de la Croix-Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient 18 years old or more
• Intubated and ventilated in intensive care unit for more than 24 hours
• Patient ready for weaning evaluation
• Failure of a first T-piece SBT

Exclusion Criteria:

• Chronic neuromuscular disease
• Guillain-Barré Syndrome
• Central nervous system disease with consciousness disorder
• Tracheostomy
• Chronic disease with life expectancy less than 1 year
• Pregnancy, breast feeding
• Withholding life support regarding a reintubation
• Prisoner or patient interned in psychiatric hospital
• Guardianship
• Language barrier
• Lack of medical insurance
• Lack of the patient's consent (or of the next of kin where appropriate)
• Patient under an exclusion period after enrollment in another research study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assisted strategy; Ability to be weaned is determined with pressure support and positive end-expiratory pressure.	Procedure: Assisted strategy; Daily spontaneous breathing trial (SBT) with 7 cmH2O pressure support and 5 cmH2O positive end-expiratory pressure are performed to assess weanability. In case of success, a SBT with T-piece is performed to determine if the patients is at high risk of extubation failure. In this case and/or in the presence of risk factors, systematic non-invasive ventilation is applied after extubation.
Active Comparator: Non assisted strategy; Ability to be weaned is determined with T-piece.	Procedure: Non assisted strategy; Daily spontaneous breathing trials (SBT) with T-piece are performed to assess weanability. In the presence of risk factors, systematic non-invasive ventilation is applied after extubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time (hours) to successful extubation	Successful extubation is defined as extubation without retintubation within the 7 following days.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of first extubation	percentage (%) of patients with a first successful extubation divided by the total number of patients per group	90 days
Invasive mechanical ventilation duration	time (hours) spent on invasive mechanical ventilation since inclusion	90 days
duration of non-invasive and invasive mechanical ventilation	time (hours) spent on invasive or non mechanical ventilation since inclusion	90 days
ventilator-free days at Day 90	90 minus the number of days spent on invasive mechanical ventilation (days) since inclusion. Zero day is allocated to dead patients.	90 days
Intensive care unit length of stay	time (days) spent in intensive care unit from inclusion until discharge or death	90 days
hospital length of stay	time (days) spent in the hospital from inclusion until discharge or death	90 days
Day 90 mortality	percentage (%) of patients dead at Day 90	90 days
reintubation rate	percentage (%) of the number of patients with any reintubation divided by the number of patients per group	90 days

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Critical care; positive end-expiratory pressure; spontaneous breathing trial; T-piece; difficult weaning
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 69HCL18_0982; 2019-A00106-51 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No