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Challenges with recruitment
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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 5 business days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorder Center of Alabama | Birmingham | Alabama | 35213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Clinician Participants | Clinicians will apply the mask adhesive to the participants and will complete ease-of-use measures. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Adult patients treated with NIV (Non-Invasive Ventilation). Patients wore the AF541 mask with or without mask adhesive for one night in randomized order. Since this was a crossover study with so few participants, baseline data was presented for the overall patient population. Demographic data was not collected for clinician participants, so baseline data is not available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Participants | Adult patients treated with NIV (Non-Invasive Ventilation) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | Up to 5 business days |
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Duration of study participation (Up to five business days from beginning to end of study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Participants | Adult patients treated with NIV (Non-Invasive Ventilation) No adverse events were reported, therefore, there was no need to compare the frequency of AEs between treatment arms. Adverse events were not collected for Clinicians participants. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chuck Cain | Philips | 412-657-1814 | chuck.cain@philips.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2020 | Dec 8, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
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| ID | Term |
|---|---|
| D008397 | Masks |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
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| 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. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
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| Participants |
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| Primary | 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) | One participant did not complete overall impressions due to study on hold and then terminated. | Posted | Mean | Standard Deviation | units on a scale | Initial Impressions at Baseline and Overall Impressions at Study Completion (After at least two mask applications) |
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| Secondary | 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. | Absolute within-subject difference in leak: [Mask with mask adhesive] - [Mask without mask adhesive] | Posted | Median | Full Range | Liters per minute | Up to 5 business days |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D012141 |
| Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D000067393 | Personal Protective Equipment |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
|