Intubation Complication
Conditions
Keywords
Endotracheal Tube, Securement, Facial skin tear, Lip ulcer, Critical 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.
Interventions
DEVICEElastic Adhesive Strips
Securement of Endotracheal tube with Elastic Adhesive Strips
DEVICELace in A Protective Sheath
Securement of Endotracheal tube with Lace in A Protective Sheath
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Cluster and Crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peribuccal lesion | 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. |
Countries
France
Outcome results
None listed