Assessment of a Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes

Endotracheal intubation is the trans laryngeal placement of a tube into the trachea via the
nose or mouth. Subglottic suctioning, during endotracheal tube securement, is important for
mechanically-ventilated patients to allow for the clearance of secretions that may accumulate
during intubation. This protocol examines an enhancement to the current AnchorFast Guard
device in order for the device to hold a subglottic suctioning lumen in addition to the
intubation tube.

Inclusion Criteria:

- Is 18 years of age or older and requires oral tracheal intubation

- Has intact skin on application site

- Is qualified to participate in the opinion of the Investigator including the
requirement for endotracheal tube with subglottic suction

Exclusion Criteria:

- Has an existing neck injury

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

- Has facial hair

- Has clinically significant skin damage, condition or disease on the application site
which may contraindicate participation

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

- Uses of topical drugs, lotions, creams or oils on the application site

- Is participating in any clinical testing which may affect performance of this device

- AnchorFast Guard Oral Endotracheal Tube Fastener does not fit subject's face