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Assessment of Novel Respiratory Protective Devices in Healthcare

NCT ID: NCT02082158

Last Updated: 2016-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-05-31

Brief Summary

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This VA-based study will obtain feedback from healthcare workers via validated survey instrument on the comfort and tolerability of wearing current models of N95 respirators and novel respirator designs currently in development. There will be 4 novel respirators and 1 commonly used respirator (not locally used) to compare to a locally used respirator, which is familiar to participants. Comparisons will be examined between each of the first 5 models with the locally used control using Dunnett's t-test.

Detailed Description

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This study aims to compare novel designs to products currently in the marketplace by comparing scores on a survey tool which measures comfort and tolerability of respiratory protective devices. Study participants will be clinical healthcare workers who have experience wearing respiratory protective devices in their workplace. We will enroll up to 400 participants in the study, made up of physicians, nurses, nursing assistants and other healthcare employees who have previously been fit-tested to a N95 respirator. Subjects will be screened to determine eligibility and must pass fit-testing on the respirator he/she is randomized to. Participants will wear the respirator while performing a series of motions that simulate movements made by healthcare workers when performing patient care tasks. There will be no contact with patients during participation. Feedback via validated survey tool will be collected from all study participants on the comfort and tolerability of the respirator worn.

Conditions

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Comfort Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Local Respirator Model

Subjects randomized to the local respirator model will wear that model while performing study procedures.

Group Type ACTIVE_COMPARATOR

Study Procedures

Intervention Type OTHER

Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.

Non-Local Respirator Model

Subjects randomized to the non-local respirator design will wear that model while performing study procedures.

Group Type ACTIVE_COMPARATOR

Study Procedures

Intervention Type OTHER

Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.

Prototype 1 Respirator Design

Subjects randomized to the prototype 1 respirator design will wear that model while performing study procedures.

Group Type EXPERIMENTAL

Study Procedures

Intervention Type OTHER

Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.

Prototype 2 Respirator Design

Subjects randomized to the prototype 2 respirator design will wear that model while performing study procedures.

Group Type EXPERIMENTAL

Study Procedures

Intervention Type OTHER

Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.

Prototype 3 Respirator Design

Subjects randomized to the prototype 3 respirator design will wear that model while performing study procedures.

Group Type EXPERIMENTAL

Study Procedures

Intervention Type OTHER

Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.

Prototype 4 Respirator Design

Subjects randomized to the prototype 4 respirator design will wear that model while performing study procedures.

Group Type EXPERIMENTAL

Study Procedures

Intervention Type OTHER

Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.

Interventions

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Study Procedures

Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* VA or UF Health Shands Hospital clinical healthcare worker
* Has been previously fit-tested to a N95 respirator
* Is able to pass fit-testing on the model of respirator he/she is randomized to

* Is pregnant
* Has a health condition that prevents him/her from wearing a respirator
* Has physical characteristics that may interfere with his/her ability to attain an adequate facial seal when fit-tested (e.g. growth of facial hair, facial scarring)
* Has any condition which could, in the opinion of the investigator, place the participant at risk or interfere with data integrity. This includes a previous reaction to inhalation of both the Bitrex or saccharin solution used during fit-testing procedures.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role collaborator

National Center for Occupational Health and Infection Control

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lewis J Radonovich, MD

Role: PRINCIPAL_INVESTIGATOR

US Department of Veterans Affairs

Locations

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Malcom Randall VA Medical Center

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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201300693

Identifier Type: -

Identifier Source: org_study_id