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The Physiological Impact of N95 Masks on Medical Staff

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.
 
ClinicalTrials.gov Identifier: NCT00173017
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date September 15, 2005
Study Start Date  ICMJE August 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
EEG change, ABG change, change in scores of attention test, etc
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
symptoms wearing N95 masks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Physiological Impact of N95 Masks on Medical Staff
Official Title  ICMJE The Physiological Impact of N95 Masks on Medical Staff
Brief Summary Wearing N95 masks may have adverse physical effect on medical staff
Detailed Description

Wearing N95 masks results in hypooxygenemia and hypercapnia which reduce working efficiency and the ability to make correct decision.

Medical staff are at increased risk of getting 'Severe acute respiratory syndrome'(SARS), and wearing N95 masks is highly recommended by experts worldwide. However, dizziness, headache, and short of breath are commonly experienced by the medical staff wearing N95 masks. The ability to make correct decision may be hampered, too. The purpose of the study was therefore to evaluate the physiological impact of N95 mask on medical staff.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Diagnostic
Condition  ICMJE
  • Hypoxemia
  • Hypercapnia
Intervention  ICMJE Device: wearing N95 masks
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 12, 2005)
20
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • medical staff

Exclusion Criteria:

  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00173017
Other Study ID Numbers  ICMJE 9261700712
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tze-Wah Kao, master National Taiwan University
PRS Account National Taiwan University Hospital
Verification Date June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP