Covid19, Respiratory Failure
Conditions
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).
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
Interventions
DEVICEMask 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.
DEVICEMask 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.
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical Adhesive-Related Skin Injury (MARSI) | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leak Change | Up to 5 business days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient Participants Adult patients treated with NIV (Non-Invasive Ventilation) | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not complete overall impressions as study was put on hold and then terminated | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Patient Participants |
|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mask With Mask Adhesive | Clinician Ease of Use | Initial Impressions | 10 units on a scale | Standard Deviation 0 |
| Mask With Mask Adhesive | Clinician Ease of Use | Overall Impressions | 10 units on a scale | — |
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).
Time frame: Up to 5 business days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mask With Mask Adhesive | Medical Adhesive-Related Skin Injury (MARSI) | 0 Participants |
| Mask Without Mask Adhesive | Medical Adhesive-Related Skin Injury (MARSI) | 0 Participants |
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.
Time frame: Up to 5 business days
Population: Absolute within-subject difference in leak: \[Mask with mask adhesive\] - \[Mask without mask adhesive\]
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mask With Mask Adhesive | Leak Change | 3.3 Liters per minute |
| Mask Without Mask Adhesive | Leak Change | 3.2 Liters per minute |
| Absolute Within-Subject Difference in Leak | Leak Change | -0.1 Liters per minute |
Comparison: Percent change in leak 100% x (\[Mask with mask adhesive\] - \[Mask without mask adhesive\])/ \[Mask without mask adhesive\]. The comparison between the two arms is captured in the reported percentage change.p-value: 0.812595% CI: [-112.6, 140.7]Wilcoxon Signed-Ranks test