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Mask Adhesive Institutional Study

Primary Purpose

Respiratory Failure, Covid19

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mask with Mask Adhesive/Arm 1

Mask without Mask Adhesive / Arm 2

About this trial

This is an interventional other trial for Respiratory Failure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Sleep Disorder Center of Alabama

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Mask with Mask Adhesive/Arm 1

Mask without Mask Adhesive/Arm 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

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)

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04644276

First Posted

November 18, 2020

Last Updated

May 24, 2023

Sponsor

Philips Clinical & Medical Affairs Global

1. Study Identification

Unique Protocol Identification Number

NCT04644276

Brief Title

Mask Adhesive Institutional Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Terminated

Why Stopped

Challenges with recruitment

Study Start Date

February 17, 2021 (Actual)

Primary Completion Date

December 9, 2021 (Actual)

Study Completion Date

December 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Philips Clinical & Medical Affairs Global

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Failure, Covid19

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mask with Mask Adhesive/Arm 1

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Mask without Mask Adhesive/Arm 2

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Mask with Mask Adhesive/Arm 1

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Mask without Mask Adhesive / Arm 2

Intervention Description

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.

Primary Outcome Measure Information:

Title

Medical Adhesive-Related Skin Injury (MARSI)

Description

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

Title

Clinician Ease of Use

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Leak Change

Description

Time Frame

Up to 5 business days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Sleep Disorder Center of Alabama

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35213

Country

United States

12. IPD Sharing Statement

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Mask Adhesive Institutional Study

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