NCT01651260

Assessment of an Endotracheal Tube Securement Device

Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Hollister Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may result in accidental slippage of the tube into a mainstream bronchus or into the pharynx. Hollister Incorporated is assessing the functionality and performance of an endotracheal tube securement device.

Detailed description

This was a multiple site assessment of the Anchor Fast with enhanced tube protection. Subjects already intubated who required a change of tube-securing device or subjects requiring intubation for greater than 24 hours who meet the inclusion and exclusion criteria were eligible to enroll into the study.The study was open to adult subjects without an existing neck injury who required oral tracheal intubation for greater than 24 hours. Subjects were required to have intact skin on the application site and to be free of facial hair, damaged skin or conditions on the application site (e.g. sunburn, scars, moles or other disfigurations), and significant skin diseases on the application site (e.g. psoriasis, eczema, atopic dermatitis, active cancer) which may have contraindicated participation.

Conditions

• Respiratory Insufficiency

Interventions

Type	Name	Description
OTHER	Experimental ET Tube Securement Device	Experimental Hollister device with bite block was substituted for standard-of-care device during the study period.

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-07-27
• Last updated: 2016-03-23
• Results posted: 2015-10-28

Locations

5 sites across 1 country: United States