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

Hollister Incorporated4 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Respiratory Depression Respiratory Failure Ventilatory Depression

Interventions

Endotracheal Tube FastenerDEVICE

The AnchorFast Guard oral endotracheal tube fastener provides a convenient means to hold an oral endotracheal tube securely in place without the use of adhesive tape. The oral endotracheal tube fastener allows repositioning of the tube in either direction along the track without removal of the device.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Legacy Mt Hood

Gresham, Oregon, United States

Legacy Good Samaritan

Portland, Oregon, United States

Legacy Salmon Creek Medical Center

Vancouver, Washington, United States

Outcomes

Primary Outcomes

Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen

Assessed by the proportion of yes/no researcher responses