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Completed

NCT Number: NCT03760510

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.

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Key information

Conditions

Mechanical Ventilation Complication

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tube Fastener

Device

Endotrachel tube secured with tube fastener

Other names: Hollister AnchorFast

Adhesive Tape

Device

Endotracheal tube secured with adhesive tape.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

The Effect of Adhesive Versus Endotracheal Tube Fastener in Critically Ill Adults: The Endotracheal Tube Securement Study

Acronym: ETTS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 30, 2018
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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