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History of Changes for Study: NCT00173017
The Physiological Impact of N95 Masks on Medical Staff
Latest version (submitted September 12, 2005) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 12, 2005 None (earliest Version on record)
Comparison Format:

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Study NCT00173017
Submitted Date:  September 12, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: 9261700712
Brief Title: The Physiological Impact of N95 Masks on Medical Staff
Official Title: The Physiological Impact of N95 Masks on Medical Staff
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2005
Overall Status: Completed
Study Start: August 2003
Primary Completion:
Study Completion: June 2005
First Submitted: September 12, 2005
First Submitted that
Met QC Criteria:
September 12, 2005
First Posted: September 15, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 12, 2005
Last Update Posted: September 15, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Taiwan University Hospital
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Hypoxemia
Hypercapnia
Keywords: N95 mask
medical staff
hypoxemia
hypercapnia
neurological study
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms:
Masking: Single (masked role unspecified)
Allocation: Randomized
Enrollment: 20
Open or close this module Arms and Interventions
Intervention Details:
Device: wearing N95 masks
Open or close this module Outcome Measures
Primary Outcome Measures:
1. EEG change, ABG change, change in scores of attention test, etc
Secondary Outcome Measures:
1. symptoms wearing N95 masks
Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • medical staff

Exclusion Criteria:

  • pregnancy
Open or close this module Contacts/Locations
Study Officials: Tze-Wah Kao, master
Principal Investigator
National Taiwan University
Locations: Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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