Endotracheal Tube Securement Study

Not Applicable

Completed

• Conditions: Mechanical Ventilation Complication
• Interventions: Device: Adhesive Tape; Device: Tube Fastener

• Registration Number: NCT03760510
• Lead Sponsor: Vanderbilt University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-17
• Primary Completion: 2018-04-14
• Study Completion: 2018-06-30
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-30
• Results First Submitted: 2019-06-19
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-08
• Last Update Submitted: 2019-07-08
• Results First Posted: 2019-07-10
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adhesive Tape	Adhesive Tape	Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
Tube Fastener	Tube Fastener	Patients in the tube fastener arm had endotrachel tube secured with tube fastener

Primary Outcome Measures

Name	Time	Method
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	48 hours post extubation up to 3 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States