Clinical trial NCT04819425: "Comparison of Two Methods of Securing Endotracheal Tubes in Intensive Care : Elastic Adhesive Strips vs Lace In A Protective Sheath."
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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Complication
Keywords: Endotracheal Tube
Securement
Facial skin tear
Lip ulcer
Critical care
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 768
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cluster and Crossover
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Peribuccal lesion
timeFrame: up to 10 days after intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Angoulême
country: France
facility: Centre Hospitalier d'Angoulême
city: Argenteuil
country: France
facility: CH Victor Dupouy
city: La Rochelle
country: France
facility: Centre Hopitalier La Rochelle
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Lorient
country: France
facility: Groupe Hospitalier Bretagne Sud
city: Nantes
country: France
facility: CHU Nantes Hôtel Dieu
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans
city: Poissy
country: France
facility: CHI Poissy - Saint-Germain-en-Laye
city: Poitiers
country: France
facility: CHU de Poitiers
city: Saint-Herblain
country: France
facility: Hôpital Nord Laennec
city: Saint-Nazaire
country: France
facility: CH Saint-Nazaire
city: Saint-Pierre
country: France
facility: CHU La Réunion GHSR
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: CHD Vendée
name: Vanessa ZINZONI
role: PRINCIPAL_INVESTIGATOR
References: