NCT04819425

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

"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"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 768 (actual)
• Sponsor: Centre Hospitalier Departemental Vendee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Elastic Adhesive Strips	Securement of Endotracheal tube with Elastic Adhesive Strips
DEVICE	Lace in A Protective Sheath	Securement of Endotracheal tube with Lace in A Protective Sheath

Timeline

• Start date: 2021-06-28
• Primary completion: 2023-08-10
• Completion: 2023-08-10
• First posted: 2021-03-29
• Last updated: 2023-11-22

Locations

13 sites across 1 country: France