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

NCT04819425 | Completed DMC

• 1 other identifier: CHD032-20
• Study Type: interventional
• Target: 768
• Locations: 1 country
• Sites: 13

Brief Summary

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.

Conditions

Intubation Complication

Keywords

Endotracheal Tube; Securement; Facial skin tear; Lip ulcer; Critical care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Device: Elastic Adhesive Strips

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.

Device: Lace in A Protective Sheath

Interventions

Elastic Adhesive Strips DEVICE

Securement of Endotracheal tube with Elastic Adhesive Strips

Elastic Adhesive Strips

Lace in A Protective Sheath DEVICE

Securement of Endotracheal tube with Lace in A Protective Sheath

Lace in A Protective Sheath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (13)

Centre Hospitalier d'Angoulême

Angoulême, France

Location

CH Victor Dupouy

Argenteuil, France

Location

Centre Hopitalier La Rochelle

La Rochelle, France

Location

Centre Hospitalier Le Mans

Le Mans, France

Location

Groupe Hospitalier Bretagne Sud

Lorient, France

Location

CHU Nantes Hôtel Dieu

Nantes, France

Location

Centre Hospitalier Régional d'Orléans

Orléans, France

Location

CHI Poissy - Saint-Germain-en-Laye

Poissy, France

Location

CHU de Poitiers

Poitiers, France

Location

Hôpital Nord Laennec

Saint-Herblain, France

Location

CH Saint-Nazaire

Saint-Nazaire, France

Location

CHU La Réunion GHSR

Saint-Pierre, France

Location

CHU de Tours

Tours, France

Location

Related Publications (1)

• 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.

  PMID: 38330026 DERIVED

Study Officials

• Vanessa ZINZONI

  CHD Vendée

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster and Crossover

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 29, 2021
• Study Start: June 28, 2021
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (13)