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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00106-51 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assisted strategy | Experimental | Ability to be weaned is determined with pressure support and positive end-expiratory pressure. |
|
| Non assisted strategy | Active Comparator | Ability to be weaned is determined with T-piece. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assisted strategy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time (hours) to successful extubation | Successful extubation is defined as extubation without retintubation within the 7 following days. | 90 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Croix-Rousse | Lyon | 69317 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36503500 | Background | 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. | |
| 38630372 |
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|
| Non assisted strategy | Procedure | 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. |
|
| 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 |
| 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. |