Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial
NCT ID: NCT03861117
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
98 participants
INTERVENTIONAL
2019-05-10
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Assisted strategy
Ability to be weaned is determined with pressure support and positive end-expiratory pressure.
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.
Non assisted strategy
Ability to be weaned is determined with T-piece.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Hôpital de la Croix-Rousse
Lyon, , France
Countries
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References
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Mezidi M, Yonis H, Chauvelot L, Danjou W, Dhelft F, Bazzani A, Girard M, Bitker L, Richard JC. Pressure support and positive end-expiratory pressure versus T-piece during spontaneous breathing trial in difficult weaning from mechanical ventilation: study protocol for the SBT-ICU study. Trials. 2022 Dec 12;23(1):993. doi: 10.1186/s13063-022-06896-4.
Mezidi M, Yonis H, Chauvelot L, Deniel G, Dhelft F, Gaillet M, Noirot I, Folliet L, Chabert P, David G, Danjou W, Baboi L, Bettinger C, Bernon P, Girard M, Provoost J, Bazzani A, Bitker L, Richard JC. Spontaneous breathing trial with pressure support on positive end-expiratory pressure and extensive use of non-invasive ventilation versus T-piece in difficult-to-wean patients from mechanical ventilation: a randomized controlled trial. Ann Intensive Care. 2024 Apr 17;14(1):59. doi: 10.1186/s13613-024-01290-6.
Other Identifiers
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2019-A00106-51
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL18_0982
Identifier Type: -
Identifier Source: org_study_id