Mask Adhesive Institutional Study

Study Overview
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Brief Summary
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To reduce interface leak and aerosol spread, Philips has developed an accessory to non-invasive ventilation(NIV) masks to be used with the Philips AF531 and the PerformaTrak mask on respiratory failure patients. For the purposes of capturing initial mask leak and safety data, this trial will enroll patients treated with NIV in an institutional setting (i.e., sleep lab).

Detailed Description
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The Mask Adhesive will serve as an accessory to the AF531/PerformaTrak masks with the intention to reduce patient leak while a patient is receiving therapy. This accessory is a double-sided adhesive; with one side applied directly to the patient's skin and the other side connected to the mask cushion. Each adhesive is only to be applied to a patient once. The AF531/Performatrak mask can be removed from the adhesive and then re-applied, as necessary. For example, if the patient needs to remove the mask to eat or take medicine, the mask is removed from the patient and the adhesive will stay on the patient's face

Official Title
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Feasibility Study of a Mask Adhesive in Patients Treated With NIV in an Institutional Setting

Conditions
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Respiratory Failure, Covid19

Intervention / Treatment
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* Device: Mask with Mask Adhesive/Arm 1
* Device: Mask without Mask Adhesive / Arm 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults patients age 18 to 85 (inclusive) Adult patients treated with NIV Able to read, write, and speak English Able to provide written informed consent Willing to have facial hair removed for adhesive placement (if required) Exclusion Criteria: Pre-existing allergy to tape or adhesive; Blisters, open skin or pre-existing skin condition that may impact the ability to support removal of the mask adhesive without tearing the skin pregnant (for females of childbearing age); Individuals sentenced to such an institution under a criminal or civil statute, Individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mask with Mask Adhesive/Arm 1<br>Patients will be randomized to AF531 if they receive mask adhesive with mask on the first study night then the mask without mask adhesive(Performatrak) on the second study night. | Device: Mask with Mask Adhesive/Arm 1<br>* Patients will be randomized to Arm1 if they receive the mask adhesive and mask on the first study night then the mask without the mask adhesive on the second study night.<br>|
| Placebo Comparator: Mask without Mask Adhesive/Arm 2<br>Patients will be randomized to Arm 2 if they receive the mask without mask adhesive on the first study night then they will receive the mask with the mask adhesive on the second study night. | Device: Mask without Mask Adhesive / Arm 2<br>* Patients will be randomized to Arm 2 if they receive the mask without mask adhesive on the first study night then the mask adhesive with the mask on the second study night.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Adhesive-Related Skin Injury (MARSI) | Percentage of patients who have severe and extreme skin irritation that persists for ≥ 30 min after mask adhesive removal (score of ≥ 3 on a 5-point grading system). | Up to 5 business days | 
| Clinician Ease of Use | Clinician-perceived mask adhesive ease-of-use as measured by a 0-10 Likert Scale at baseline (initial impressions) and study completion (overall impressions) Specifically, the item, How would you rate the ease of application of the adhesive to the mask? (On a 0 to 10 scale, with 0=Extremely Difficult and 10=Extremely Easy) | Initial Impressions at Baseline and Overall Impressions at Study Completion (After at least two mask applications) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leak Change | Change in leak volume (L/min) after mask adhesive use as compared to the use of the mask without the adhesive. Percent change in leak (endpoint per protocol) is reported in the Statistical Analysis section. | Up to 5 business days |