Mask Adhesive Institutional Study

Not Applicable

Terminated

Interventions: Device: Mask without Mask Adhesive / Arm 2
Device: Mask with Mask Adhesive/Arm 1

Brief Summary: 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: 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

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Mask without Mask Adhesive/Arm 2	Mask without Mask Adhesive / Arm 2	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.
Mask with Mask Adhesive/Arm 1	Mask with Mask Adhesive/Arm 1	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.

Primary Outcome Measures

Name	Time	Method
Medical Adhesive-Related Skin Injury (MARSI)	Up to 5 business days	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).
Clinician Ease of Use	Initial Impressions at Baseline and Overall Impressions at Study Completion (After at least two mask applications)	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)

Secondary Outcome Measures

Name	Time	Method
Leak Change	Up to 5 business days	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.