Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial

Not Applicable

Completed

• Conditions: Critically Ill Adult Patients With Difficult Weaning
• Interventions: Procedure: Non assisted strategy; Procedure: Assisted strategy

• Registration Number: NCT03861117
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-04
• Study Start: 2019-05-10
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non assisted strategy	Non assisted strategy	Ability to be weaned is determined with T-piece.
Assisted strategy	Assisted strategy	Ability to be weaned is determined with pressure support and positive end-expiratory pressure.

Primary Outcome Measures

Name	Time	Method
Time (hours) to successful extubation	90 days	Successful extubation is defined as extubation without retintubation within the 7 following days.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital de la Croix-Rousse; 🇫🇷 Lyon, France