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

Not Applicable

Terminated

Conditions: Respiratory Failure
Respiratory Depression
Ventilatory Depression

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

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Endotracheal Tube Fastener	Endotracheal Tube Fastener	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen	Typical wear time of endotracheal tube fastener up to one week	Assessed by the proportion of yes/no researcher responses
Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve	Typical wear time of endotracheal tube fastener up to one week	Assessed by the proportion of researcher responses that equal agree (4) plus strongly agree (5) on a five point scale that includes strongly disagree (1) disagree (2) and no opinion (3)
Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen	Typical wear time of endotracheal tube fastener up to one week	Assessed by the proportion of yes/no researcher responses
Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning	Typical wear time of endotracheal tube fastener up to one week	Assessed by the proportion of yes/no researcher responses
Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract	Typical wear time of endotracheal tube fastener up to one week	Assessed by the proportion of yes/no researcher responses

Secondary Outcome Measures

Name	Time	Method

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