Endotracheal Tube Securement Study

NCT03760510 | Completed Results FDA Device

• 1 other identifier: IRB #170596
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation Complication

Keywords

endotracheal tube; tube fastener; facial skin tear; lip ulcer; endotracheal tube dislodgement

Outcome Measures

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

  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 Outcomes (3)

• Number of Participants With Lip Ulcers

  48 hours post extubation up to 3 months

• Number of Participants With Facial Skin Tear

  48 hours post extubation up to 3 months

• Number of Participants With Ett Dislodgement

  duration of intubation up to 3 months

Study Arms (2)

Adhesive Tape

EXPERIMENTAL

Patients in adhesive tape arm had endotracheal tube secured with adhesive tape

Device: Adhesive Tape

Tube Fastener

EXPERIMENTAL

Patients in the tube fastener arm had endotrachel tube secured with tube fastener

Device: Tube Fastener

Interventions

Tube Fastener DEVICE

Endotrachel tube secured with tube fastener

Also known as: Hollister AnchorFast

Tube Fastener

Adhesive Tape DEVICE

Endotracheal tube secured with adhesive tape.

Adhesive Tape

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Landsperger JS, Byram JM, Lloyd BD, Rice TW; Pragmatic Critical Care Research Group. The effect of adhesive tape versus endotracheal tube fastener in critically ill adults: the endotracheal tube securement (ETTS) randomized controlled trial. Crit Care. 2019 May 7;23(1):161. doi: 10.1186/s13054-019-2440-7.

  PMID: 31064406 DERIVED

MeSH Terms

Interventions

Surgical Tape

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Janna Landsperger
• Organization: Vanderbilt University Medical Center

janna.landsperger@vumc.org

6153223412

Study Officials

• Janna Landsperger, ACNP

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 30, 2018
• Study Start: May 17, 2017
• Primary Completion: April 14, 2018
• Study Completion: June 30, 2018
• Last Updated: July 10, 2019
• Results First Posted: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)