Assessment of an Endotracheal Tube Securement Device

Study Overview
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Brief Summary
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Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may result in accidental slippage of the tube into a mainstream bronchus or into the pharynx. Hollister Incorporated is assessing the functionality and performance of an endotracheal tube securement device.

Detailed Description
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This was a multiple site assessment of the Anchor Fast with enhanced tube protection. Subjects already intubated who required a change of tube-securing device or subjects requiring intubation for greater than 24 hours who meet the inclusion and exclusion criteria were eligible to enroll into the study.The study was open to adult subjects without an existing neck injury who required oral tracheal intubation for greater than 24 hours. Subjects were required to have intact skin on the application site and to be free of facial hair, damaged skin or conditions on the application site (e.g. sunburn, scars, moles or other disfigurations), and significant skin diseases on the application site (e.g. psoriasis, eczema, atopic dermatitis, active cancer) which may have contraindicated participation.

Official Title
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Assessment of the Functionality and Performance of an Endotracheal (ET) Tube Protection Device

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Other: Experimental ET Tube Securement Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is 18 years of age or older; male or female and requiring oral tracheal intubation. Has intact skin on application site. Willingly signs or their authorized representative willingly signs the Informed Consent. Is qualified to participate in the opinion of the Investigator. Exclusion Criteria: Has an existing neck injury. Has protruding upper teeth, without teeth or is unable to wear upper dentures. Has facial hair. Has clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer. Has damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site. Has a known or stated allergy to adhesive bandages, or any of the product types being tested. Uses of topical drugs on the application site. Uses lotions, creams or oils on the application site. Currently is participating in any clinical testing which may affect performance of this device. Has been previously intubated with skin irritation or pressure sores surrounding the mouth.

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 |
| --- | --- |
| Other: Endotracheal (ET) tube securement device<br>Single arm study evaluated an experimental ET tube securement device with a bite block. | Other: Experimental ET Tube Securement Device<br>* Experimental Hollister device with bite block was substituted for standard-of-care device during the study period.<br>* Other names: AnchorFast Guard® ET tube securement device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use | Number of participants with damage of ET tube and Number of participants with occlusion of ET tube | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Use | Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy); | Between 1 - 14 days |