Endotracheal Tube Securement Study

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of endotracheal tube securement techniques, a pragmatic, randomized controlled trial will compare the effect of adhesive tape versus endotracheal tube fastener on complications including lip ulcers, facial skin tears, endotracheal tube dislodgement, and ventilator associated pneumonia among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.

Detailed Description
-----------------
Background: The optimal securement method of endotracheal tubes is unknown, but should provide adequate security while minimizing complications. This study tests the hypothesis that use of an endotracheal tube fastener would reduce complications among critically ill adults undergoing endotracheal intubation. This hypothesis will be tested in a pragmatic, single center, randomized trial comparing the effect of adhesive tape versus endotracheal tube fastener (Hollister) among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.

Official Title
-----------------
The Effect of Adhesive Versus Endotracheal Tube Fastener in Critically Ill Adults: The Endotracheal Tube Securement Study

Conditions
-----------------
Mechanical Ventilation Complication

Intervention / Treatment
-----------------
* Device: Tube Fastener
* Device: Adhesive Tape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient intubated prior to admission to the MICU and the intubation time was less than 12 hours from the time of admission Patients intubated in the MICU for greater than 24 hours Exclusion Criteria: intubated greater than 12 hours prior to admission to the MICU presence of oral mucosa or facial skin breakdown prior to enrollment required nasotracheal intubation, had a documented allergy to tape pregnant prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The endotracheal tube securement study was a pragmatic, single center, open-label, randomized trial comparing the effect of adhesive tape versus endotracheal tube fastener (Hollister AnchorFast Guard) among critically ill adults requiring intubation and mechanical ventilation for at least 24 hours.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adhesive Tape<br>Patients in adhesive tape arm had endotracheal tube secured with adhesive tape | Device: Adhesive Tape<br>* Endotracheal tube secured with adhesive tape.<br>|
| Experimental: Tube Fastener<br>Patients in the tube fastener arm had endotrachel tube secured with tube fastener | Device: Tube Fastener<br>* Endotrachel tube secured with tube fastener<br>* Other names: Hollister AnchorFast;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Any Incidence of the Following: Presence of Lip Ulcer, Endotracheal Tube Dislodgement, or Facial Skin Tears From the Time of Randomization to the Earlier of Death or 48 Hours After Extubation | Rate per 1000 ventilator days of any incidence of the following: presence of lip ulcer, endotracheal tube dislodgement, or facial skin tears from the time of randomization to the earlier of death or 48 hours after extubation | 48 hours post extubation up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Lip Ulcers | Presence of lip ulcer | 48 hours post extubation up to 3 months | 
| Number of Participants With Facial Skin Tear | presence of facial skin tear | 48 hours post extubation up to 3 months | 
| Number of Participants With Ett Dislodgement | frequency of ett dislodgement | duration of intubation up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endotracheal tube, tube fastener, facial skin tear, lip ulcer, endotracheal tube dislodgement