Assessment of an Endotracheal Tube Securement Device

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.

Inclusion Criteria:

- Is 18 years of age or older; male or female and requiring oral tracheal intubation.

- Has intact skin on application site.

- Willingly signs or their authorized representative willingly signs the Informed
Consent.

- Is qualified to participate in the opinion of the Investigator.

Exclusion Criteria:

- Has an existing neck injury.

- Has protruding upper teeth, without teeth or is unable to wear upper dentures.

- Has facial hair.

- Has clinically significant skin diseases on the application site which may
contraindicate participation, including psoriasis, eczema, atopic dermatitis, active
cancer.

- Has damaged skin or conditions on the application site which includes sunburn, scars,
moles or other disfiguration of the test site.

- Has a known or stated allergy to adhesive bandages, or any of the product types being
tested.

- Uses of topical drugs on the application site.

- Uses lotions, creams or oils on the application site.

- Currently is participating in any clinical testing which may affect performance of
this device.

- Has been previously intubated with skin irritation or pressure sores surrounding the
mouth.