Respiratory FailureNCT04644276

Mask Adhesive Institutional Study

A study testing Mask with Mask Adhesive/Arm 1 and Mask without Mask Adhesive / Arm 2 in people with Respiratory Failure and Covid19, run by Philips Clinical & Medical Affairs Global at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Failure, Covid19
What is being tested?: Mask with Mask Adhesive/Arm 1 and Mask without Mask Adhesive / Arm 2
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 17 Feb 2021to 9 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Sleep Disorder Center of Alabama
Birmingham, Alabama, 35213

Other trials in United States

About this study

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

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).

Read the 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

Conditions: Respiratory Failure, Covid19
Being tested: Mask with Mask Adhesive/Arm 1, Mask without Mask Adhesive / Arm 2
Medical subject headings: Respiratory Insufficiency, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT04644276
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Mask without Mask Adhesive / Arm 2

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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.
Measured: Up to 5 business days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 20219 Dec 2021

First posted25 Nov 2020
Study start17 Feb 2021
Primary completion9 Dec 2021
Study completion9 Dec 2021

Why it stopped: Challenges with recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04644276
Sponsor's protocol ID: SRCHRCMask Adhesive 2020_11130
Status last verified: May 2023
First submitted: 18 Nov 2020
Last updated: 26 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Respiratory Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study of a Mask Adhesive in Patients Treated With NIV in an Institutional Setting
ClinicalTrials.gov ID: NCT04644276
Acronym / sponsor ID: SRCHRCMask Adhesive 2020_11130
Conditions: Respiratory Failure, Covid19
Study type: Interventional
Recruitment status: TerminatedReason stopped: Challenges with recruitment
Enrolment: 7 participants (actual)
Lead sponsor: Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
Study start: 17 Feb 2021 (actual)
Primary completion: 9 Dec 2021 (actual)
Study completion: 9 Dec 2021 (actual)
First posted: 25 Nov 2020 (actual)
Results: Posted 26 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mask with Mask Adhesive/Arm 1	Active comparator	Device: Mask with Mask Adhesive/Arm 1Patients 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.
Mask without Mask Adhesive/Arm 2	Placebo comparator	Device: Mask without Mask Adhesive / Arm 2Patients 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mask with Mask Adhesive/Arm 1Patients 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.	Device	Mask with Mask Adhesive/Arm 1
Mask without Mask Adhesive / Arm 2Patients 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.	Device	Mask without Mask Adhesive/Arm 2

Primary outcome

Medical Adhesive-Related Skin Injury (MARSI)
Time frame: 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
Time frame: 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)

1 secondary outcome

Leak Change
Time frame: Up to 5 business days

Results and safety

Results posted to the registry on 26 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mask With Mask Adhesive Then Mask Without Mask Adhesive	2	2
Mask Without Mask Adhesive Then Mask With Mask Adhesive	3	3
Clinician Participants	2	1

Primary outcome: Medical Adhesive-Related Skin Injury (MARSI)

Time frame: Up to 5 business days. Count of participants. Unit: Participants

Measure	Mask With Mask Adhesive n = 5	Mask Without Mask Adhesive n = 5
Value	0	0

Primary outcome: Clinician Ease of Use

Time frame: Initial Impressions at Baseline and Overall Impressions at Study Completion (After at least two mask applications). Mean (Standard Deviation). Unit: units on a scale

Measure	Clinician Participants n = 2
Initial Impressions	10 (0)
Overall Impressions	10 (NA)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Duration of study participation (Up to five business days from beginning to end of study). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patient Participants	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 3
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medical Adhesive-Related Skin Injury (MARSI) (time frame: Up to 5 business days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04644276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.