Assessment of an Oral Endotracheal Subglottic Tube Holder

Study Overview
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Brief Summary
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This study is designed to assess the acceptability and usability of a new Endotracheal Tube (ET) holding device for an orally intubated patient.

Detailed Description
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This is a multiple site prospective assessment of the study product in ICU settings. The study is comprised of each intubated subject wearing one study product until the device either needs to be changed or is no longer required by the subject. The study product is designed to hold a standard or subglottic ET tube and help reduce the potential for occlusion (blockage) of the tube.

Official Title
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Assessment of AnchorFast Guard Subglottic ET (Endotracheal) Tube

Conditions
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Intubation

Intervention / Treatment
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* Device: New oral endotracheal tube holder


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Is 18 years of age or older and require oral tracheal intubation with subglottic ET tube size 6.0-8.0mm Requires the use of a bite block per the hospital's standard of care Has intact skin on and around application site, including cheeks and lips Oral cavity is free of open sores, ulcers, wounds, and lesions Subject or Legal Authorized representative (LAR) able to provide informed consent for the study Is qualified to participate in the opinion of the Investigator, or designee EXCLUSION CRITERIA Has actual or perceived loose teeth, is without teeth, or is unable to wear upper dentures Has facial hair that interferes with the adhesion of the skin barrier pads Has a clinically significant skin disease or condition, or damaged skin on the application site, such as psoriasis, eczema, atopic dermatitis, active cancer, sores, sunburns, scars, moles Has a medical condition, surgery or a procedure that prevents the proper application of the device, including placement of the neck strap. Has a known or stated allergy to adhesives Currently is participating in any clinical study which may affect the performance of the device

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New oral endotracheal tube holder<br>Single Study Product Arm | Device: New oral endotracheal tube holder<br>* The single arm study product is designed to hold a standard or subglottic ET tube.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Acceptability With Study Product | The overall acceptability relating to general experience with the study product during use will be rated with a 5-point Likert scale ranging from 1=Very Unacceptable to 5=Very Acceptable | At product removal (maximum 29 days of patient wearing product) | 
| Usability of Study Product | The usability of the study product at application and at removal. | At application and product removal (maximum 29 days of patient wearing product) |