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

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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Key information

Conditions

Intubation Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier d'Angoulême, Angoulême, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elastic Adhesive Strips

Device

Securement of Endotracheal tube with Elastic Adhesive Strips

Lace in A Protective Sheath

Device

Securement of Endotracheal tube with Lace in A Protective Sheath

Primary outcomes

Peribuccal lesion

Time frame: up to 10 days after intubation

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Official study title

"Comparison of Two Methods of Securing Endotracheal Tubes in Intensive Care : Elastic Adhesive Strips vs Lace In A Protective Sheath. A Randomized Multicenter, Cluster and Crossover Controlled Study. FIXATUB"

Acronym: FIXATUB

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Mar 29, 2021
Registry last updated: Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed