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The aim of this clinical trial is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.
Participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.
This is a prospective, randomised, controlled trial. The aim of this study is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.
Inclusion : Participants who meet eligibility criteria will be randomized into experimental arm (endotracheal suctioning during positive pressure extubation) or control arm (no endotracheal suction during positive pressure extubation).
Intervention and Follow-up : participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.
End of study : at the end of the study visit (28 days after extubation), vital status of participants will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suctionning Extubation (experimental arm) | Experimental | Endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit. |
|
| No Suctionning Extubation (control arm) | Sham Comparator | No endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suctionning extubation | Procedure | We will remove the intubation tube with endotracheal suctioning during the extubation procedure and maintain positive end expiratory pressure (PEEP) and pressure support. The PEEP level will be 10 cmH2O and the pressure support 7 cmH2O for 2 minutes prior to extubation. The vacuum level will be the maximum level (standard procedure in the unit), i.e. 450 mmHg. The closed-system suction probe is inserted up to the last mark corresponding to 40cm. The size of our closed system is identical for all patients, i.e. 14 french. |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratoy/oxygenation index (ROX index) | Rox index will be assessed 3 hours after extubation by an investigator with no information about randomization (blind assessment) | 3 hours after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical ventilation weaning failure | Weaning failure corresponds with death or new intabution | During 7 days after extubation |
| ROX index evolution | Rox index will be assessed 3 times after extubation in order to evaluate its evolution (blind assessment) :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cécile FOSSAT | Contact | +33238575252 | fanny.louat@chu-orleans.fr | |
| Fanny LOUAT | Contact | +33238744295 | fanny.louat@chu-orleans.fr |
| Name | Affiliation | Role |
|---|---|---|
| Cécile FOSSAT | Centre Hospitalier Universitaire d'Orléans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire d'Orléans | Recruiting | Orléans | Loiret | 45067 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11934711 | Background | Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med. 2002 Apr 1;165(7):867-903. doi: 10.1164/ajrccm.165.7.2105078. | |
| 18367735 | Background | Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447. |
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| No suctionning Extubation | Procedure | In the control group, removal of the intubation tube during the extubation procedure is performed with PEEP maintained, without endotracheal suctioning. The PEEP level will be set at 10 cmH2O and the pressure at 7 cmH2O in the 2 minutes prior to extubation. |
|
| During 3 hours after extubation |
| Pneumonia after extubation | Rate of hospital-acquired pneumonia confirmed by an investigator | During 7 days after extubation |
| Airway clearance technique | Use of any airway clearance technique after extubation :
| During 24 hours after extubation |
| 17470624 | Background | Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206. |
| 21376523 | Background | Frutos-Vivar F, Esteban A, Apezteguia C, Gonzalez M, Arabi Y, Restrepo MI, Gordo F, Santos C, Alhashemi JA, Perez F, Penuelas O, Anzueto A. Outcome of reintubated patients after scheduled extubation. J Crit Care. 2011 Oct;26(5):502-509. doi: 10.1016/j.jcrc.2010.12.015. Epub 2011 Mar 3. |
| 36878644 | Background | Fossat G, Desmalles E, Courtes L, Fossat C, Boulain T. Cough Peak Flow Assessment Without Disconnection From the ICU Ventilator in Mechanically Ventilated Patients. Respir Care. 2023 Apr;68(4):470-477. doi: 10.4187/respcare.10412. Epub 2023 Mar 6. |