Assessment of an Oral Endotracheal SubglotticTube Holder

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.

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