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

Intubation Complication Clinical Trial

— FIXATUB  

Official 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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04819425
• Other study ID #: CHD032-20
• Status: Completed
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: August 10, 2023

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 768
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intubation Complication

Intervention

Device:
• 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

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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