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

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

Detailed Description
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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.

Official Title
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Assessment of AnchorFast Guard Oral Endotracheal Tube Fastener on Patients Intubated With Oral Endotracheal Tubes With Subglottic Suction

Conditions
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Respiratory Depression, Respiratory Failure, Ventilatory Depression

Intervention / Treatment
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* Device: Endotracheal Tube Fastener


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endotracheal Tube Fastener<br>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. | Device: Endotracheal Tube Fastener<br>* 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.<br>* Other names: AnchorFast Guard Oral Endotracheal Tube Fastener;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Typical wear time of endotracheal tube fastener up to one week | 
| Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve | 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) | Typical wear time of endotracheal tube fastener up to one week | 
| Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract | Assessed by the proportion of yes/no researcher responses | Typical wear time of endotracheal tube fastener up to one week | 
| Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen | Assessed by the proportion of yes/no researcher responses | Typical wear time of endotracheal tube fastener up to one week | 
| Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning | Assessed by the proportion of yes/no researcher responses | Typical wear time of endotracheal tube fastener up to one week |