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

Hollister

Status: Terminated

Conditions: Respiratory Failure; Respiratory Depression; Ventilatory Depression

Treatments: Device: Endotracheal Tube Fastener

Study type: Interventional

Funder types: Industry

Identifiers

NCT02760927

5799-I

Details and patient eligibility

About

Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated with Oral Endotracheal Tubes with Subglottic Suction

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Endotracheal Tube Fastener

Experimental group

Description:

The intervention administered is a revised commercially available endotracheal tube holder with a tract to accommodate a subglottic suction lumen of an oral endotracheal tube.

Treatment:

Device: Endotracheal Tube Fastener