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Endotracheal Tube Securement Study (ETTS)

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status

Completed

Conditions

Mechanical Ventilation Complication

Treatments

Device: Tube Fastener
Device: Adhesive Tape

Study type

Interventional

Funder types

Other

Identifiers

NCT03760510
IRB #170596

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

500 participants in 2 patient groups

Adhesive Tape
Experimental group
Description:
Patients in adhesive tape arm had endotracheal tube secured with adhesive tape
Treatment:
Device: Adhesive Tape
Tube Fastener
Experimental group
Description:
Patients in the tube fastener arm had endotrachel tube secured with tube fastener
Treatment:
Device: Tube Fastener

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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