NCT03760510

Endotracheal Tube Securement Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Mechanical Ventilation Complication

Interventions

Type	Name	Description
DEVICE	Tube Fastener	Endotrachel tube secured with tube fastener
DEVICE	Adhesive Tape	Endotracheal tube secured with adhesive tape.

Timeline

• Start date: 2017-05-17
• Primary completion: 2018-04-14
• Completion: 2018-06-30
• First posted: 2018-11-30
• Last updated: 2019-07-10
• Results posted: 2019-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study