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NCT02082158 · ClinicalTrials.gov registry record · NA

Assessment of Novel Respiratory Protective Devices in Healthcare

A NA study of Tolerability and Comfort, sponsored by National Center for Occupational Health and Infection Control.

Completed
Registry status
NA
Development phase
382
Enrollment target
1
Study location

NCT02082158: Completed NA study of Tolerability and Comfort, sponsored by National Center for Occupational Health and Infection Control.

NCT02082158 is a NA study of Tolerability and Comfort that has completed, run by National Center for Occupational Health and Infection Control. The registered enrollment target is 382 participants, above the 119-participant average among 4 other Tolerability trials with a reported enrollment target (221% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02082158, a NA study of Tolerability and Comfort, has completed, sponsored by National Center for Occupational Health and Infection Control.

COMPLETED
Registry status
NA
Development phase
382 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

Subject will participate in set study activities wearing the respirator that he/she was randomized to. Following, Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. The Respirator Comfort, Wearing Experience and Function Instr

Conditions Studied

Interventions

  • OTHER Study Procedures

Study Locations (1)

Florida

  • Malcom Randall VA Medical Center - Gainesville

Trial Details

FieldValue
Enrollment Target 382 participants
Start Date 2014-07
Est. Completion 2015-05
Phase NA

What the finished NCT02082158 record still lists

NCT02082158 is an interventional study that assigns participants to a tested intervention. The registered 382 participants enrollment target is mid-sized for trials with a published cap, above the 119-participant average among 4 other Tolerability trials with a reported enrollment target (221% higher).

The record links to 2 conditions, with Tolerability appearing as the primary indexed condition, and to 1 intervention - of which Study Procedures is the first listed.

NCT02082158 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT02082158 about?

NCT02082158 is a clinical study titled "Assessment of Novel Respiratory Protective Devices in Healthcare". 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 l...

What is the current status of trial NCT02082158?

This trial is currently completed. It is a NA study. The enrollment target is 382 participants. The study started on 2014-07. Estimated completion is 2015-05.

What conditions does trial NCT02082158 study?

This clinical trial studies the following conditions: Tolerability, Comfort.

What interventions are being tested in trial NCT02082158?

The interventions under investigation include: Study Procedures (OTHER).

Who is sponsoring clinical trial NCT02082158?

This trial is sponsored by National Center for Occupational Health and Infection Control, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02082158 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT02082158, the US trial registry maintained by the National Library of Medicine. NCT02082158 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.