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In intensive care unit (ICU), mechanical ventilation (MV) is part of routine care.
Weaning phase is a daily preoccupation for the caregivers. Prolonged MV can lead to many complications. Failing the weaning phase expose the patient to the need for reintubation, that improves the mortality.
The caregiver faces a major problem, in one hand the need to wean properly and quickly and on the other the risk of reintubation.
In order to help the clinician making the good choice, the spontaneous breathing trial (SBT) is a key tool. The international literature provides the investigators many ways to perform the SBT. The most common is the T-piece; the patient is disconnected from the ventilator and connected to a T-piece that can provide supplemental oxygen. Another one is the Support pressure trial, the patient is still connected to the ventilator, but the setups are changed to recreate the T-piece conditions.
In many French ICU's, the SBT is performed by using a heat humidifier filter that is directly connected to the endotracheal tube, this filter allows the clinician to provide supplemental oxygen in accordance with the patient need.
In high risk for reintubation patients, the SBT can create physical stress, that lead to prolonged MV.
In our ICU, for those patients, the investigators perform the SBT by connecting the patient to a device that provides high flow oxygen trough endotracheal connector for tracheotomy.
The investigators hypothesis that high flow oxygen SBT, will allow the high risk for reintubation patients to succeed the SBT.
The investigators proposed to compare 2 strategies for SBT in high risk for reintubation patients:
This prospective randomized study had 2 conjoint primary outcome:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Classic SBT (C-SBT) | No Intervention | The patient is disconnected from the ventilator and remains 30 minutes without support but oxygen delivered through a heat humidifier filter that is usually connected on tracheotomy. | |
| 2. High Flow Oxygen SBT (HFO-SBT) | Experimental | The patient is disconnected from the ventilator and remains 30 minutes without support but high flow oxygen delivered through a dedicated piece that is usually connected on tracheotomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow Oxygen SBT | Procedure | The patient is disconnected from the ventilator and remains 30 minutes without support but high flow oxygen delivered through a dedicated piece that is usually connected on tracheotomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Actuarial rate of extubation | This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients:
This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients:
| Day 7 |
| Reintubation Rate | This prospective randomized study had 2 conjoint primary outcomes to ensure the safety for the patients:
| Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of the first SBT | Success rate of the first SBT will be compared between the two groups. | Day 0 |
| Ventilator free-days | Ventilator free-days at day 28 from the admission in ICU |
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Inclusion Criteria:
Age > 18 yrs.
Admission in ICU
Mechanically ventilated > 24 hours
Mechanically ventilated using support ventilation mode
Patient with one of these criterion:
Informed and signed consent from the patient or next of kin.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mai-Anh NAY, Dr | CHR d'Orléans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR d'Orleans | Orléans | 45067 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23641924 | Background | Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI. | |
| 24865303 | Background | Ladeira MT, Vital FM, Andriolo RB, Andriolo BN, Atallah AN, Peccin MS. Pressure support versus T-tube for weaning from mechanical ventilation in adults. Cochrane Database Syst Rev. 2014 May 27;2014(5):CD006056. doi: 10.1002/14651858.CD006056.pub2. |
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| Day 28 |
| Rate of Ventilator Associated Pneumonia | Rate of Ventilator Associated Pneumonia at day 7 from the extubation | Day 7 |
| 7921460 | Background | Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460. |