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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00334-39 | Other Identifier | ID RCB/ANSM |
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| Name | Class |
|---|---|
| Direction Générale de l'Offre de Soins | OTHER_GOV |
| Hospices Civils de Lyon | OTHER |
| the EXSUPEEP study was supported by a grant from the French Ministry of Health (MoH-fr) | UNKNOWN |
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Extubation in intensive care unit is a risky situation. Its failure is associated with an increase in the duration of mechanical ventilation and high morbidity and mortality.
Our hypothesis is that the extubation procedure associating prior endotracheal aspiration followed by ablation of the intubation probe under the application of a PEEP, would make it possible both to avoid the leakage of secretions towards the lower airways and the alveolar recruitment, compared to extubation with concomitant endotracheal aspiration.
By these mechanisms, this extubation procedure combining prior endotracheal aspiration followed by ablation of the tube under the application of a PEEP, would make it possible to increase the ventilator free days from any mechanical ventilation.
Extubation consists of several distinct phases: obtaining the weaning criteria, succeeding weaning test and then removing the intubation tube.
While the first two stages are the subject of numerous publications, the last one is rarely studied. To reduce the risk of failure of extubation, the scientific societies of intensive care medicine have published recommendations. They relate to patient weaning and weaning testing, but there are no clear recommendations for the procedure for removing the intubation tube.
The ablation of the tube, performed by the chest physiotherapist or nurse, typically involves endotracheal aspiration, from deflation of the cuff to removal of the intubation tube.
The objective is theoretically to prevent the secretions accumulated above the cuff, at the pharyngeal level, from falling into the lower airways.
Laboratory data show that inhalation of secretions appears to be greater during ablation of the tube with concomitant endotracheal aspiration, which creates a reverse pressure gradient, propelling the secretions into the lower airways. The application of Positive Expiratory Pressure during the ablation of the tube would help to combat this phenomenon. At the same time, this Positive Expiratory Pressure could have a beneficial effect on alveolar recruitment.
Recent work proves the non-inferiority of the ablation of the tube with the application of a Positive Expiratory Pressure versus the so-called "reference" method, consisting of endotracheal aspiration during the ablation of the tube.
We wish to conduct a comparative, prospective, randomized, multicenter study comparing extubation with concomitant endotracheal aspiration versus ablation of the intubation tube under the application of a PEEP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEEP Extubation With Positive End-Expiratory Pressure | Experimental | endo-tracheal aspiration followed by the application of PEEP = 10 cm of H2O, maintained for 3 minutes (reventilation and rest time) and continued until the end of the procedure removal of the extubation |
|
| Aspiration Extubation With SUctioning | Active Comparator | endo-tracheal aspiration concomitant with removal of extubation. Suction is maintained throughout the intubation tube ablation procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extubation with PEEP | Procedure | No aspiration within the 3 minutes before extubation and extubation with 10cmH2O PEEP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator free days at the 28th day | The primary endpoint is the number of mechanical ventilation-free days (invasive and non-invasive) after the first extubation procedure | From DZéro to D27 |
| Measure | Description | Time Frame |
|---|---|---|
| Re-intubation rate | The re-intubation rate (%) within seven days following the removal of the Extubation Procedure | 7 days (from Dzéro to D6) |
| Cumulated duration of non invasive ventilation (NIV) and High flow oxygenation (HFO) |
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Inclusion criteria
Firstly, the decision to extubate must be made by the treating clinicians after having validated that the clinical criteria for weaning are met, namely: according to the international conference consensus on weaning , patients will be considered as ready for an initial SBT as soon as they meet all of the following criteria:
Patients meeting any of the following criteria will be included in the EXSUPEEP trial:
Exclusion criteria
Patients meeting any of the following criteria will be excluded from the EXSUPEEP trial:
Patients with personal NIV or continuous positive airway pressure at home will be included if Pressure Support (PS) and/or PEEP used in the ICU unit are different from the usual settings at home. Regarding infection by SARS-CoV-2 or use of endotracheal tubes with subglottic suction, they do not constitute an exclusion criterion.
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas SEDILLOT | CH Bourg en Bresse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Orléans | Orléans | Orléans | France | |||
| CH Annecy Genevois |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39947817 | Derived | Sedillot N, Kallel H, Robine A, Pineda JA, Quenot JP, Servant M, Levrat A, Damieux-Verdeau C, Mezidi M, Thibert N, Bohe J, Ballesteros-Calzado A, Stevic N, Mahi L, Sigaud F, Maisonneuve M, Thiery G, Prat P, Thille AW, Haouat S, Plantefeve G, Decullier E, Rabilloud M, Bernon P, Poncelin Y, Bonnici JC. Applying positive end-expiratory pressure before and during endotracheal tube removal versus extubation with concomitant aspiration: protocol for the randomised controlled multicentre EXSUPEEP trial. BMJ Open. 2025 Feb 13;15(2):e092354. doi: 10.1136/bmjopen-2024-092354. |
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| Endotracheal Aspiration | Procedure | Aspiration during cuff deflation |
|
Duration marked in hours , same for NIV and HFO
| 7 days (from Dzéro to D6) |
| Proportion of patients with pneumonia and/or atelectasis | radiological assessment of pneumonia and/or atelectasis. A systematic chest radiography is to be done at 72 hours and 7 days after extubation procedure. | within 72 hours ( D2) and within 7 days ( D6) |
| Rate of Respiratory acute failure (RAF) | Percentage of included patients who with clinical RAF after extubation procedure | Within 7 days (from Dzéro to D6) |
| Lenght of stay in Intensive care unit (ICU) and in hospital | Marked in days. | within 28 days |
| Rate of death | Whatever the cause of death for included patients | Within 28 days (from Dzero to Day 27) |
| Annecy |
| France |
| CH Victor Dupouy | Argenteuil | France |
| CH Bourg en Bresse | Bourg-en-Bresse | France |
| CHU Francois Mitterand | Dijon | France |
| CHU Michallon | Grenoble | France |
| HCL Croix Rousse | Lyon | France |
| HCL Edouard Herriot | Lyon | France |
| HCL Lyon Sud | Lyon | France |
| CHU La Miletrie | Poitiers | France |
| Hopital Nord | Saint-Etienne | France |
| ID | Term |
|---|---|
| D060666 | Airway Extubation |
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D012121 | Respiration, Artificial |
| D012138 | Respiratory Therapy |
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