Mask Adhesive Institutional Study

Philips

Status: Terminated

Conditions: Respiratory Failure; Covid19

Treatments: Device: Mask with Mask Adhesive/Arm 1; Device: Mask without Mask Adhesive / Arm 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04644276

SRCHRCMask Adhesive 2020_11130

Details and patient eligibility

About

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).

Full 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

Enrollment: 7 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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7 participants in 2 patient groups, including a placebo group

Mask with Mask Adhesive/Arm 1

Active Comparator group

Description:

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.

Treatment:

Device: Mask with Mask Adhesive/Arm 1

Mask without Mask Adhesive/Arm 2

Placebo Comparator group

Description:

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.

Treatment:

Device: Mask without Mask Adhesive / Arm 2