Clinical trial NCT03760510: Endotracheal Tube Securement Study
Official title: The Effect of Adhesive Versus Endotracheal Tube Fastener in Critically Ill Adults: The Endotracheal Tube Securement Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Keywords: endotracheal tube
tube fastener
facial skin tear
lip ulcer
endotracheal tube dislodgement
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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
timeFrame: 48 hours post extubation up to 3 months
Secondary outcomes:
measure: Number of Participants With Lip Ulcers
timeFrame: 48 hours post extubation up to 3 months
measure: Number of Participants With Facial Skin Tear
timeFrame: 48 hours post extubation up to 3 months
measure: Number of Participants With Ett Dislodgement
timeFrame: duration of intubation up to 3 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Janna Landsperger, ACNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Landsperger JS, Byram JM, Lloyd BD, Rice TW; Pragmatic Critical Care Research Group. The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial. Crit Care. 2019 May 7;23(1):161. doi: 10.1186/s13054-019-2440-7.