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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02151-56 | Other Identifier | ID-RCB |
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The main objective will be to compare the number of ventilator-free days within the 28 days following the first spontaneous breathing trial between strategies of extubation performing spontaneous breathing trials with T-piece trials or with Pressure-Support trials.
To do that, the study director proposed to conduct a prospective multicenter randomized controlled open-label trial comparing these 2 strategies of weaning in patients at high-risk of extubation failure in the Intensive Care Unit.
Patients included will be randomized before performing the first spontaneous breathing trial and will be assigned to one of the following two groups according to the weaning strategy: T-piece trial group or Pressure-Support trial group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-piece trial | Active Comparator | In patients assigned to control group all spontaneous breathing trials will be performed using T-piece trial. |
|
| Pressure-Support trial | Experimental | In patients assigned to experimental group all spontaneous breathing trials will be performed with a pressure-support level of 8 cm H2O without positive end-expiratory pressure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-piece trial | Procedure | T-piece trial will be performed for around 1 hour with a T-piece connected to the extremity of the endotracheal tube by simply disconnecting the patient from the ventilator and by providing additional oxygen (≤ 6 L/min) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ventilator-free days at day 28 | The number of ventilator-free days at day 28, defined as the number of days alive and without invasive mechanical ventilation (intubation or tracheostomy) between the first spontaneous breathing trial (day 1) and day 28. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of days alive and without mechanical ventilation (including intubation or non-invasive ventilation) between the first spontaneous breathing trial (day 1) and day 28. | Between Day 1 and Day 28 | |
| The number of patients extubated within the 72 hours and within the 7 days following the first spontaneous breathing trial. |
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Inclusion Criteria:
Duration of mechanical ventilation prior to the first spontaneous brathing trial > 24h
Patients at high-risk of reintubation according to the following criteria: Patients older than 65 years, or those having any underlying chronic cardiac or lung disease.
Patient meeting all weaning criteria according to the international conference consensus on weaning.
Informed consent given by the relatives or the patient himself.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud W. THILLE, Pr | CHU Poitiers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive reanimation | Poitiers | 86000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41168567 | Derived | Metais M, Frat JP, Ehrmann S, Pene F, Decavele M, Terzi N, Prat G, Martin M, Contou D, Gacouin A, Bourenne J, Girault C, Vinsonneau C, Dellamonica J, Labro G, Jochmans S, Herbland A, Quenot JP, Devaquet J, Benzekri D, Ragot S, Thille AW, Coudroy R; FLORALI-IM study group and the REVA Research Network. Factors associated with ICU mortality and long-term outcomes in immunocompromised patients admitted to the intensive care unit for acute respiratory failure. Ann Intensive Care. 2025 Oct 30;15(1):175. doi: 10.1186/s13613-025-01578-1. | |
| 38295948 |
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Data will be made available after reasonable request and it has been discussed among the steering committee
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| Pressure-support trial | Procedure | Pressure-Support trial will be performed for around 1 hour without disconnecting the patient from the ventilator, by using a low level of pressure-support (PS 8 cm H2O) with a FiO2 ≤ 40% and without positive end-expiratory pressure (PEEP), while continuously monitoring the respiratory rate and tidal volume on the ventilator display. |
|
| Hour 72, Day 7 |
| The number of patients extubated after simple (24h), difficult (> 24 hours and ≤ 7 days) or prolonged ( > 7 days) weaning | Day 28 |
| The number of patients extubated after the first spontaneous breathing trial and not reintubated within the following 72 hours. | Hour 72 |
| The number of days between the first spontaneous breathing trial and the first extubation attempt among extubated patients | Day 28 |
| The number of patients reintubated within the 72 hours and within the 7 days following extubation. | Day 28 |
| The number of patients with post-extubation respiratory failure within the 7 days following extubation. | Day 28 |
| Length of stay in ICU in days. | Day 90 |
| Numbers of patients died in ICU, at day 28 and at day 90. | Day 28 and Day 90 |
| Derived |
| Coudroy R, Lejars A, Rodriguez M, Frat JP, Rault C, Arrive F, Le Pape S, Thille AW. Physiologic Effects of Reconnection to the Ventilator for 1 Hour Following a Successful Spontaneous Breathing Trial. Chest. 2024 Jun;165(6):1406-1414. doi: 10.1016/j.chest.2024.01.038. Epub 2024 Jan 29. |
| 36286317 | Derived | Thille AW, Gacouin A, Coudroy R, Ehrmann S, Quenot JP, Nay MA, Guitton C, Contou D, Labro G, Reignier J, Pradel G, Beduneau G, Dangers L, Saccheri C, Prat G, Lacave G, Sedillot N, Terzi N, La Combe B, Mira JP, Romen A, Azais MA, Rouze A, Devaquet J, Delbove A, Dres M, Bourenne J, Lautrette A, de Keizer J, Ragot S, Frat JP; REVA Research Network. Spontaneous-Breathing Trials with Pressure-Support Ventilation or a T-Piece. N Engl J Med. 2022 Nov 17;387(20):1843-1854. doi: 10.1056/NEJMoa2209041. Epub 2022 Oct 26. |
| 33234658 | Derived | Thille AW, Coudroy R, Gacouin A, Ehrmann S, Contou D, Dangers L, Romen A, Guitton C, Lacave G, Quenot JP, Lacombe B, Pradel G, Terzi N, Prat G, Labro G, Reignier J, Beduneau G, Dellamonica J, Nay MA, Rouze A, Delbove A, Sedillot N, Mira JP, Bourenne J, Lautrette A, Argaud L, Levrat Q, Devaquet J, Vivier E, Azais MA, Leroy C, Dres M, Robert R, Ragot S, Frat JP; REVA research network. T-piece versus pressure-support ventilation for spontaneous breathing trials before extubation in patients at high risk of reintubation: protocol for a multicentre, randomised controlled trial (TIP-EX). BMJ Open. 2020 Nov 24;10(11):e042619. doi: 10.1136/bmjopen-2020-042619. |