Mask Adhesive Institutional Study

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-17

Study Completion Date

2021-12-09

Brief Summary

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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).

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Detailed Description

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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

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Respiratory Failure Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mask with Mask Adhesive/Arm 1

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.

Group Type ACTIVE_COMPARATOR

Mask with Mask Adhesive/Arm 1

Intervention Type 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.

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 they will receive the mask with the mask adhesive on the second study night.

Group Type PLACEBO_COMPARATOR

Mask without Mask Adhesive / Arm 2

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes