Endotracheal Tube Securement Study

Vanderbilt University Medical Center500 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

500

Conditions

Mechanical Ventilation Complication

Interventions

Tube FastenerDEVICE

Endotrachel tube secured with tube fastener

Adhesive TapeDEVICE

Endotracheal tube secured with adhesive tape.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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

Time frame: 48 hours post extubation up to 3 months

Secondary Outcomes

Number of Participants With Lip Ulcers

Presence of lip ulcer

Time frame: 48 hours post extubation up to 3 months

Number of Participants With Facial Skin Tear

presence of facial skin tear

Time frame: 48 hours post extubation up to 3 months

Number of Participants With Ett Dislodgement

frequency of ett dislodgement

Time frame: duration of intubation up to 3 months

Data from ClinicalTrials.gov

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