Mask Adhesive Institutional Study

Philips Clinical & Medical Affairs Global7 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Respiratory Failure Covid19

Interventions

Mask with Mask Adhesive/Arm 1DEVICE

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.

Mask without Mask Adhesive / Arm 2DEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sleep Disorder Center of Alabama

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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).

Time frame: 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)

Time frame: Initial Impressions at Baseline and Overall Impressions at Study Completion (After at least two mask applications)

Secondary Outcomes

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.

Time frame: Up to 5 business days

Data from ClinicalTrials.gov

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