Endotracheal Tube Securement Study

Mechanical Ventilation Complication Clinical Trial

— ETTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03760510
• Other study ID #: IRB #170596
• Status: Completed
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 30, 2018
• Est. primary completion date: April 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Device:
• Tube Fastener
Endotrachel tube secured with tube fastener
• Adhesive Tape
Endotracheal tube secured with adhesive tape.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Lip Ulcers	Presence of lip ulcer	48 hours post extubation up to 3 months
Secondary	Number of Participants With Facial Skin Tear	presence of facial skin tear	48 hours post extubation up to 3 months
Secondary	Number of Participants With Ett Dislodgement	frequency of ett dislodgement	duration of intubation up to 3 months