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Contamination During Removal of Two Different Personal Protective Systems

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00150475
First Posted: September 8, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Queen's University
  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
Intervention Model: Crossover Assignment
Masking: Single
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00150475     History of Changes
Other Study ID Numbers: PSI 04-58
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

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

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