Trial Outcomes & Findings for Mask Adhesive Institutional Study (NCT NCT04644276)

NCT ID: NCT04644276

Last Updated: 2023-05-26

Results Overview

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).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: Up to 5 business days
• Results posted on: 2023-05-26

Participant Flow

Participant milestones

Measure	Mask With Mask Adhesive Then Mask Without Mask Adhesive Adult patients treated with NIV (Non-Invasive Ventilation). In Arm 1, patients were randomized to receive the mask with mask adhesive (Performatrak) on the first study night then the mask without mask adhesive on the second study night. Due to the small sample size baseline data was not broken out by randomized order.	Mask Without Mask Adhesive Then Mask With Mask Adhesive Adult patients treated with NIV (Non-Invasive Ventilation). In Arm 2, patients were randomized to receive the mask without mask adhesive on the first study night then the mask with mask adhesive (Performatrak) on the second study night. Due to the small sample size baseline data was not broken out by randomized order.	Clinician Participants Clinicians will apply the mask adhesive to the participants and will complete ease-of-use measures.
Overall Study STARTED	2	3	2
Overall Study COMPLETED	2	3	1
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Measure	Mask With Mask Adhesive Then Mask Without Mask Adhesive Adult patients treated with NIV (Non-Invasive Ventilation). In Arm 1, patients were randomized to receive the mask with mask adhesive (Performatrak) on the first study night then the mask without mask adhesive on the second study night. Due to the small sample size baseline data was not broken out by randomized order.	Mask Without Mask Adhesive Then Mask With Mask Adhesive Adult patients treated with NIV (Non-Invasive Ventilation). In Arm 2, patients were randomized to receive the mask without mask adhesive on the first study night then the mask with mask adhesive (Performatrak) on the second study night. Due to the small sample size baseline data was not broken out by randomized order.	Clinician Participants Clinicians will apply the mask adhesive to the participants and will complete ease-of-use measures.
Overall Study Did not complete overall impressions as study was put on hold and then terminated	0	0	1

Baseline Characteristics

Mask Adhesive Institutional Study

Baseline characteristics by cohort

Measure	Patient Participants n=5 Participants Adult patients treated with NIV (Non-Invasive Ventilation)
Age, Continuous	62.4 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Mask With Mask Adhesive n=5 Participants Results for Mask with Mask Adhesive intervention	Mask Without Mask Adhesive n=5 Participants Results for Mask without Mask Adhesive intervention	Absolute Within-Subject Difference in Leak Absolute Within-Subject Difference in Leak: \[Leak from Mask with mask adhesive\] - \[Leak from Mask without mask adhesive\]
Medical Adhesive-Related Skin Injury (MARSI)	0 Participants	0 Participants	—

PRIMARY outcome

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

Population: One participant did not complete overall impressions due to study on hold and then terminated.

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)

Outcome measures

Measure	Mask With Mask Adhesive n=2 Participants Results for Mask with Mask Adhesive intervention	Mask Without Mask Adhesive Results for Mask without Mask Adhesive intervention	Absolute Within-Subject Difference in Leak Absolute Within-Subject Difference in Leak: \[Leak from Mask with mask adhesive\] - \[Leak from Mask without mask adhesive\]
Clinician Ease of Use Initial Impressions	10 units on a scale Standard Deviation 0	—	—
Clinician Ease of Use Overall Impressions	10 units on a scale Standard Deviation NA N=1	—	—

SECONDARY outcome

Timeframe: Up to 5 business days

Population: Absolute within-subject difference in leak: \[Mask with mask adhesive\] - \[Mask without mask adhesive\]

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.

Outcome measures

Measure	Mask With Mask Adhesive n=5 Participants Results for Mask with Mask Adhesive intervention	Mask Without Mask Adhesive n=5 Participants Results for Mask without Mask Adhesive intervention	Absolute Within-Subject Difference in Leak n=5 Participants Absolute Within-Subject Difference in Leak: \[Leak from Mask with mask adhesive\] - \[Leak from Mask without mask adhesive\]
Leak Change	3.3 Liters per minute Interval 0.2 to 19.9	3.2 Liters per minute Interval 0.4 to 49.6	-0.1 Liters per minute Interval -29.7 to 4.5

Adverse Events

Patient Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chuck Cain

Philips

Phone: 412-657-1814

Email: chuck.cain@philips.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place