Contamination During Removal of Two Different Personal Protective Systems

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00150475
First received: September 6, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

Highly communicable and virulent diseases, the ongoing threat of emerging infectious diseases, and the prospect of bio-terrorism have become part of the new reality for health care workers. SARS transmission has occurred despite the use of droplet, contact, and airborne precautions. Potential explanations for some of the episodes of “through-precautions” transmission include the possibility of contamination during removal of protective clothing.

The recommended protective systems (PPS) for aerosol generating procedures set out by the US Center for Disease Control and Prevention (CDC) and the Ontario Ministry of Health and Long Term Care (MOHLTC) differ.

The failure of a PPS may be associated with significant consequences in terms of the morbidity and mortality of front-line health care workers. The purpose of this study is to determine if a difference exists between the rate of self-contamination due to deficiencies in contact precautions for individuals wearing either the CDC or MOHLTC recommended PPS.

Study participants will don one of the two recommended PPS, be “contaminated” with an indicator that becomes visible under ultraviolet light, and then assessed for contamination of clothing layers and skin after removal of the PPS. They will then repeat the procedure using the other PPS.


Condition Intervention
Severe Acute Respiratory Syndrome
Procedure: Powered Air purifying respirator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Contamination During Removal of Two Different Personal Protective Systems When Working Under Conditions Requiring Enhanced Respiratory and Contact Precautions

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • The primary endpoint of this study is the presence of any detected
  • base clothing layer, skin, or hair contamination.

Secondary Outcome Measures:
  • The secondary endpoints: 1) contamination episodes of any layer, and 2) protective
  • system donning and removal procedure violations

Estimated Enrollment: 50
Study Start Date: January 2005
Estimated Study Completion Date: May 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:Participants will be recruited from the Department of Anesthesiology attending and resident staff, other physician groups requiring PAPR training, and the Department of Respiratory Therapy.

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Exclusion Criteria:Individuals will be excluded if they refuse to provide written consent to participate in the study

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150475

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Jorge E. Zamora, MD Queen's University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00150475     History of Changes
Other Study ID Numbers: PSI 04-58
Study First Received: September 6, 2005
Last Updated: September 6, 2005
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Severe Acute Respiratory Syndrome

Additional relevant MeSH terms:
Syndrome
Severe Acute Respiratory Syndrome
Coronavirus Infections
Disease
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014