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Every year, in France, nearly 100,000 patients hospitalized in intensive care more than 48 hours require invasive respiratory assistance via an endotracheal tube.
Appropriate tube fixation is essential to ensure effective ventilation while minimizing potential complications such as accidental extubations. However, the fixation system chosen may lead to peribuccal lesions such as bedsores, shearing or cutaneous-mucous tear. These lesions are painful for patients and often unsightly as scar may remain.
There are no formal recommendations for the use of any type of fixing system. Thus, systems used to secure the endotracheal tube vary from one ICU to another.
The objective of this study is to demonstrate that the fixing strategy by elastic adhesive tape reduces the risk of developing a peribuccal lesion during the time of the endotracheal tube's maintenance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elastic Adhesive Strips | Experimental | Endotracheal tube fixed by elastic adhesive tape (Tensoplast type adhesive tape): The adhesive tape will be attached to the patient's face (opposite side to the endotracheal tube) and then two turns around the endotracheal tube will be made. The rest of the adhesive tape will be attached to the other side of the face (side of the endotracheal tube). The laminated tape will be kept on the adhesive tape until it passes over the neck in order to avoid adhering to the hair. Finally, the end of the adhesive tape will be replaced on the part already attached to the patient. It will be changed daily and after stain or examinations if necessary. |
|
| Lace in A Protective Sheath | Active Comparator | A loop is made with the lace then the endotracheal tube is passed through the loop. The loop is tightened by pulling each side on the remaining cords and a knot is made on one side of the fastener. It will be changed daily and after stain or examinations if necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elastic Adhesive Strips | Device | Securement of Endotracheal tube with Elastic Adhesive Strips |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peribuccal lesion | Appearance of at least one peribuccal lesion during the first 10 days of maintaining the endotracheal tube inserted orally. Presence of peribuccal lesion will be validated on picture by an independent review committee. The picture will be taken daily without the visible fixing system (blind maintained for the adjudication committee) from J0 to J10 at the site of the endotracheal tube. | up to 10 days after intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa ZINZONI | CHD Vendée | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Angoulême | Angoulême | France | ||||
| CH Victor Dupouy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38330026 | Derived | Zinzoni V, Planche L, Le Potier S, Robin L, Le Parco C, Terrat P, Leroyer MH, Atger R, Dauvergne JE, Muller L, Fontaine L, Morand C, Dennemont P, Paillard O, Vastral S, Dardaine B, Le Guillou S, Maquigneau N, Martin S, Lacherade JC. Impact of two endotracheal tube fixation on the incidence of peri-oral lesions: Elastic adhesive strips versus cord in a protective sheath. Study protocol for a cluster cross-over randomized trial. PLoS One. 2024 Feb 8;19(2):e0297349. doi: 10.1371/journal.pone.0297349. eCollection 2024. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 27, 2026 | |
| Reset | Jun 22, 2026 |
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Cluster and Crossover
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| Lace in A Protective Sheath | Device | Securement of Endotracheal tube with Lace in A Protective Sheath |
|
| Argenteuil |
| France |
| Centre Hopitalier La Rochelle | La Rochelle | France |
| Centre Hospitalier Le Mans | Le Mans | France |
| Groupe Hospitalier Bretagne Sud | Lorient | France |
| CHU Nantes Hôtel Dieu | Nantes | France |
| Centre Hospitalier Régional d'Orléans | Orléans | France |
| CHI Poissy - Saint-Germain-en-Laye | Poissy | France |
| CHU de Poitiers | Poitiers | France |
| Hôpital Nord Laennec | Saint-Herblain | France |
| CH Saint-Nazaire | Saint-Nazaire | France |
| CHU La Réunion GHSR | Saint-Pierre | France |
| CHU de Tours | Tours | France |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 27, 2026 | Jun 22, 2026 |