Endotracheal Tube Securement Study (ETTS)
July 8, 2019 updated by: Todd Rice, Vanderbilt University Medical Center
The Effect of Adhesive Versus Endotracheal Tube Fastener in Critically Ill Adults: The Endotracheal Tube Securement Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adhesive Tape
Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
|
Endotracheal tube secured with adhesive tape.
|
|
Experimental: Tube Fastener
Patients in the tube fastener arm had endotrachel tube secured with tube fastener
|
Endotrachel tube secured with tube fastener
Other Names:
|
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
Time Frame: 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
|
48 hours post extubation up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Lip Ulcers
Time Frame: 48 hours post extubation up to 3 months
|
Presence of lip ulcer
|
48 hours post extubation up to 3 months
|
|
Number of Participants With Facial Skin Tear
Time Frame: 48 hours post extubation up to 3 months
|
presence of facial skin tear
|
48 hours post extubation up to 3 months
|
|
Number of Participants With Ett Dislodgement
Time Frame: duration of intubation up to 3 months
|
frequency of ett dislodgement
|
duration of intubation up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Janna Landsperger, ACNP, Vanderbilt University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 17, 2017
Primary Completion (Actual)
April 14, 2018
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
November 26, 2018
First Submitted That Met QC Criteria
November 28, 2018
First Posted (Actual)
November 30, 2018
Study Record Updates
Last Update Posted (Actual)
July 10, 2019
Last Update Submitted That Met QC Criteria
July 8, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- IRB #170596
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
publication in a peer-reviewed medical journal
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.