Mask Adhesive Institutional Study
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Device: Mask with Mask Adhesive/Arm 1
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.
|
| Placebo Comparator: 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. |
Device: 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 the mask adhesive with the mask on the second study night.
|
Outcome Measures
Primary Outcome Measures
- Medical Adhesive-Related Skin Injury (MARSI) and Ease of Use [30 days]
Proportion 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-perceived mask adhesive ease of use as measured by a 0-10 Likert Scale with 0 being extremely difficult and 10 being extremely easy (initial impressions/end of study).
Secondary Outcome Measures
- Leak Change [30 days]
Calculated percentage change in leak volume (L/min) after mask adhesive use as compared to the use of the mask without the adhesive.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults patients age 18 to 85 (inclusive)
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Adult patients treated with NIV
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Able to read, write, and speak English
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Able to provide written informed consent
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Willing to have facial hair removed for adhesive placement (if required)
Exclusion Criteria:
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Pre-existing allergy to tape or adhesive;
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Blisters, open skin or pre-existing skin condition that may impact the ability to support removal of the mask adhesive without tearing the skin
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pregnant (for females of childbearing age);
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Individuals sentenced to such an institution under a criminal or civil statute,
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sleep Disorder Center of Alabama | Birmingham | Alabama | United States | 35213 |
Sponsors and Collaborators
- Philips Clinical & Medical Affairs Global
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SRCHRCMask Adhesive 2020_11130