Assessment of an Oral Endotracheal Subglottic Tube Holder

Hollister

Status: Completed

Conditions: Intubation

Treatments: Device: New oral endotracheal tube holder

Study type: Interventional

Funder types: Industry

Identifiers

NCT03328182

5855-I

Details and patient eligibility

About

This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.

Full description

This is a multiple site prospective assessment of the study product in ICU settings. The study is comprised of each intubated subject wearing one study product until the device either needs to be changed or is no longer required by the subject. The study product is designed to hold a standard or subglottic ET tube and help reduce the potential for occlusion (blockage) of the tube.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

1. Is 18 years of age or older and require oral tracheal intubation with subglottic ET tube size 6.0-8.0mm
2. Requires the use of a bite block per the hospital's standard of care
3. Has intact skin on and around application site, including cheeks and lips
4. Oral cavity is free of open sores, ulcers, wounds, and lesions
5. Subject or Legal Authorized representative (LAR) able to provide informed consent for the study
6. Is qualified to participate in the opinion of the Investigator, or designee

EXCLUSION CRITERIA

1. Has actual or perceived loose teeth, is without teeth, or is unable to wear upper dentures
2. Has facial hair that interferes with the adhesion of the skin barrier pads
3. Has a clinically significant skin disease or condition, or damaged skin on the application site, such as psoriasis, eczema, atopic dermatitis, active cancer, sores, sunburns, scars, moles
4. Has a medical condition, surgery or a procedure that prevents the proper application of the device, including placement of the neck strap.
5. Has a known or stated allergy to adhesives
6. Currently is participating in any clinical study which may affect the performance of the device

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

New oral endotracheal tube holder

Experimental group

Description:

Single Study Product Arm

Treatment:

Device: New oral endotracheal tube holder