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Endotracheal Tube Securement Study (ETTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03760510
Recruitment Status : Completed
First Posted : November 30, 2018
Results First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mechanical Ventilation Complication Device: Tube Fastener Device: Adhesive Tape Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Adhesive Versus Endotracheal Tube Fastener in Critically Ill Adults: The Endotracheal Tube Securement Study
Actual Study Start Date : May 17, 2017
Actual Primary Completion Date : April 14, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arms and Interventions
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Arm Intervention/treatment
Experimental: Adhesive Tape
Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
 Device: Adhesive Tape
Endotracheal tube secured with adhesive tape.
Experimental: Tube Fastener
Patients in the tube fastener arm had endotrachel tube secured with tube fastener
 Device: Tube Fastener
Endotrachel tube secured with tube fastener
Other Name: Hollister AnchorFast


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of Participants With Lip Ulcers [ Time Frame: 48 hours post extubation up to 3 months ]
    Presence of lip ulcer

  2. Number of Participants With Facial Skin Tear [ Time Frame: 48 hours post extubation up to 3 months ]
    presence of facial skin tear

  3. Number of Participants With Ett Dislodgement [ Time Frame: duration of intubation up to 3 months ]
    frequency of ett dislodgement


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760510


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Janna Landsperger, ACNP Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Todd Rice, Vanderbilt University Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] March 21, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Todd Rice, Associate Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03760510    
Other Study ID Numbers: IRB #170596
First Posted: November 30, 2018    Key Record Dates
Results First Posted: July 10, 2019
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: publication in a peer-reviewed medical journal

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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
Keywords provided by Todd Rice, Vanderbilt University Medical Center:
endotracheal tube
tube fastener
facial skin tear
lip ulcer
endotracheal tube dislodgement