The Physiological Impact of N95 Masks on Medical Staff

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ClinicalTrials.gov Identifier: NCT00173017

Recruitment Status : Completed

First Posted : September 15, 2005

Last Update Posted : September 15, 2005

View this study on Beta.ClinicalTrials.gov

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

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

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

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

Current Responsible Party

Not Provided

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

National Taiwan University Hospital

Original Study Sponsor ^ICMJE

Same as current

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

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