NCT03861117CompletedNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Time (hours) to successful extubation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Assisted strategy
Experimental
Ability to be weaned is determined with pressure support and positive end-expiratory pressure.
Intervention: Assisted strategy (Procedure)
Non assisted strategy
Active Comparator
Ability to be weaned is determined with T-piece.
Intervention: Non assisted strategy (Procedure)
Outcomes
Primary Outcomes
Time (hours) to successful extubation
Time Frame: 90 days
Successful extubation is defined as extubation without retintubation within the 7 following days.
Secondary Outcomes
- ventilator-free days at Day 90(90 days)
- Day 90 mortality(90 days)
- reintubation rate(90 days)
- Rate of first extubation(90 days)
- duration of non-invasive and invasive mechanical ventilation(90 days)
- Intensive care unit length of stay(90 days)
- Invasive mechanical ventilation duration(90 days)
- hospital length of stay(90 days)
Investigators
Study Sites (1)
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