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Mask Adhesive Institutional Study

NCT04644276 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-05-26

Study results available
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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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Philips Clinical & Medical Affairs Global

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-17
Primary Completion
2021-12-09
Completion
2021-12-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04644276 on ClinicalTrials.gov