"Comparison of Two Methods of Securing Endotracheal Tubes in Intensive Care : Elastic Adhesive Strips vs Lace In A Protective Sheath." (FIXATUB)

Centre Hospitalier Departemental Vendee

Status: Completed

Conditions: Intubation Complication

Treatments: Device: Lace in A Protective Sheath; Device: Elastic Adhesive Strips

Study type: Interventional

Funder types: Other

Identifiers

NCT04819425

CHD032-20

Details and patient eligibility

About

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.

Enrollment: 768 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient hospitalized in Intensive Care Unit
• 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

• Pre-existing face lesions at ICU admission along the path of the endotracheal tube fixing.
• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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768 participants in 2 patient groups

Elastic Adhesive Strips

Experimental group

Description:

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.

Treatment:

Device: Elastic Adhesive Strips

Lace in A Protective Sheath

Active Comparator group

Description:

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.

Treatment:

Device: Lace in A Protective Sheath