NCT04644276

Mask Adhesive Institutional Study

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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

Conditions

• Respiratory Failure
• Covid19

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-02-17
• Primary completion: 2021-12-09
• Completion: 2021-12-09
• First posted: 2020-11-25
• Last updated: 2023-05-26
• Results posted: 2023-05-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study