Back to resultsPressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial (SBT-ICU)
Primary Purpose
Critically Ill Adult Patients With Difficult Weaning
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assisted strategy
Non assisted strategy
Sponsored by
About this trial
This is an interventional treatment trial for Critically Ill Adult Patients With Difficult Weaning focused on measuring Critical care, spontaneous breathing trial, T-piece, positive end-expiratory pressure, difficult weaning
Eligibility Criteria
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
Sites / Locations
- Hôpital de la Croix-Rousse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Assisted strategy
Non assisted strategy
Arm Description
Ability to be weaned is determined with pressure support and positive end-expiratory pressure.
Ability to be weaned is determined with T-piece.
Outcomes
Primary Outcome Measures
Time (hours) to successful extubation
Successful extubation is defined as extubation without retintubation within the 7 following days.
Secondary Outcome Measures
Rate of first extubation
percentage (%) of patients with a first successful extubation divided by the total number of patients per group
Invasive mechanical ventilation duration
time (hours) spent on invasive mechanical ventilation since inclusion
duration of non-invasive and invasive mechanical ventilation
time (hours) spent on invasive or non mechanical ventilation since inclusion
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.
Intensive care unit length of stay
time (days) spent in intensive care unit from inclusion until discharge or death
hospital length of stay
time (days) spent in the hospital from inclusion until discharge or death
Day 90 mortality
percentage (%) of patients dead at Day 90
reintubation rate
percentage (%) of the number of patients with any reintubation divided by the number of patients per group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03861117
Brief Title
Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial
Acronym
SBT-ICU
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Adult Patients With Difficult Weaning
Keywords
Critical care, spontaneous breathing trial, T-piece, positive end-expiratory pressure, difficult weaning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assisted strategy
Arm Type
Experimental
Arm Description
Ability to be weaned is determined with pressure support and positive end-expiratory pressure.
Arm Title
Non assisted strategy
Arm Type
Active Comparator
Arm Description
Ability to be weaned is determined with T-piece.
Intervention Type
Procedure
Intervention Name(s)
Assisted strategy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non assisted strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time (hours) to successful extubation
Description
Successful extubation is defined as extubation without retintubation within the 7 following days.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Rate of first extubation
Description
percentage (%) of patients with a first successful extubation divided by the total number of patients per group
Time Frame
90 days
Title
Invasive mechanical ventilation duration
Description
time (hours) spent on invasive mechanical ventilation since inclusion
Time Frame
90 days
Title
duration of non-invasive and invasive mechanical ventilation
Description
time (hours) spent on invasive or non mechanical ventilation since inclusion
Time Frame
90 days
Title
ventilator-free days at Day 90
Description
90 minus the number of days spent on invasive mechanical ventilation (days) since inclusion. Zero day is allocated to dead patients.
Time Frame
90 days
Title
Intensive care unit length of stay
Description
time (days) spent in intensive care unit from inclusion until discharge or death
Time Frame
90 days
Title
hospital length of stay
Description
time (days) spent in the hospital from inclusion until discharge or death
Time Frame
90 days
Title
Day 90 mortality
Description
percentage (%) of patients dead at Day 90
Time Frame
90 days
Title
reintubation rate
Description
percentage (%) of the number of patients with any reintubation divided by the number of patients per group
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hôpital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
12. IPD Sharing Statement
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Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial
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