Mask Adhesive Institutional Study

NCT04644276 | Terminated Results FDA Device

• 1 other identifier: SRCHRCMask Adhesive 2020_11130
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 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).

Conditions

Respiratory Failure; Covid19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Leak Change

  Up to 5 business days

Study Arms (2)

Mask with Mask Adhesive/Arm 1

ACTIVE COMPARATOR

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

Mask without Mask Adhesive/Arm 2

PLACEBO COMPARATOR

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

Interventions

Mask with Mask Adhesive/Arm 1 DEVICE

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 with Mask Adhesive/Arm 1

Mask without Mask Adhesive / Arm 2 DEVICE

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.

Mask without Mask Adhesive/Arm 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Sleep Disorder Center of Alabama

Birmingham, Alabama, 35213, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; COVID-19

Interventions

Masks

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Chuck Cain
• Organization: Philips

chuck.cain@philips.com

412-657-1814

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 25, 2020
• Study Start: February 17, 2021
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: May 26, 2023
• Results First Posted: May 26, 2023

Record last verified: 2023-05

Locations

US (1)