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

November 21, 2023 updated by: Centre Hospitalier Departemental Vendee

"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"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

768

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angoulême, France
        • Centre Hospitalier d'Angoulème
      • Argenteuil, France
        • CH Victor Dupouy
      • La Rochelle, France
        • Centre Hopitalier La Rochelle
      • Le Mans, France
        • Centre Hospitalier Le Mans
      • Lorient, France
        • Groupe Hospitalier Bretagne Sud
      • Nantes, France
        • CHU Nantes Hôtel Dieu
      • Orléans, France
        • Centre Hospitalier Régional D'orléans
      • Poissy, France
        • CHI Poissy - Saint-Germain-en-Laye
      • Poitiers, France
        • Chu de Poitiers
      • Saint-Herblain, France
        • Hôpital Nord Laennec
      • Saint-Nazaire, France
        • CH Saint-Nazaire
      • Saint-Pierre, France
        • CHU La Réunion GHSR
      • Tours, France
        • CHU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Elastic Adhesive Strips
Securement of Endotracheal tube with Elastic Adhesive Strips
Active Comparator: 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.
Device: Lace in A Protective Sheath
Securement of Endotracheal tube with Lace in A Protective Sheath

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 10 days after intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Principal Investigator: Vanessa ZINZONI, CHD Vendee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2021

Primary Completion (Actual)

August 10, 2023

Study Completion (Actual)

August 10, 2023

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHD032-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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