"Comparison of Two Methods of Securing Endotracheal Tubes in Intensive Care : Elastic Adhesive Strips vs Lace In A Protective Sheath."
NCT ID: NCT04819425
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
768 participants
INTERVENTIONAL
2021-06-28
2023-08-10
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Elastic Adhesive Strips
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.
Elastic Adhesive Strips
Securement of Endotracheal tube with Elastic Adhesive Strips
Lace in A Protective Sheath
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.
Lace in A Protective Sheath
Securement of Endotracheal tube with Lace in A Protective Sheath
Interventions
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Elastic Adhesive Strips
Securement of Endotracheal tube with Elastic Adhesive Strips
Lace in A Protective Sheath
Securement of Endotracheal tube with Lace in A Protective Sheath
Eligibility Criteria
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Inclusion Criteria
* Age over 18
* Intubation for estimated duration \> 48h
* Patient treated with vasopressors
* Patient or relative who received the information and are not opposed to study participation or patient included under the emergency procedure in the absence of contactable family members.
Exclusion Criteria
* Admitted patient already intubated upon transfer from another ICU
* Nasotracheal intubation
* Patient in isolation for suspected COVID or clinically proven COVID
* Admitted tracheotomized patient
* Pregnant, nursing, parturient woman
* Lack of social security affiliation
* Moribund
* Incapable major (under guardianship, curatorship)
* Patient deprived of liberty by court order
18 Years
ALL
No
Sponsors
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Centre Hospitalier Departemental Vendee
OTHER
Responsible Party
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Principal Investigators
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Vanessa ZINZONI
Role: PRINCIPAL_INVESTIGATOR
CHD Vendée
Locations
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Centre Hospitalier d'Angoulême
Angoulême, , France
CH Victor Dupouy
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
Countries
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References
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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.
Other Identifiers
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CHD032-20
Identifier Type: -
Identifier Source: org_study_id