- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02265926
Respiratory Consequences of N95-type Mask Usage in Pregnant Healthcare Workers - A Controlled Clinical Study
October 15, 2014 updated by: Pearl Tong, National University Health System, Singapore
The study aims to find out if usage of N95 type respirators affects respiratory parameters in pregnant women so as to provide guidance on N95 respirator usage in pregnant healthcare workers.
Study Overview
Detailed Description
The first phase of the study aims to determine the average workload of a nurse.
In the second phase of the study, this workload is then translated to walking on a treadmill while pregnant subjects wore special masks open to air, then occluded with N95 mask materials.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Singapore, Singapore, 119228
- NUHS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Subjects had spontaneously conceived singleton pregnancies and were between 21 to 40 years old. Their hemoglobin levels were ≥11g/dL
Exclusion Criteria:
- Any cardiorespiratory illness, influenza-like illness in the week prior to the trial, or any pregnancy-related complications such as gestational diabetes, hypertension, intrauterine growth restriction, placenta previa, ruptured membranes, or threatened preterm labor. Any neuromuscular conditions that would preclude them from using the treadmill.
Haemoglobinopathies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: N95
Intervention: N95 mask material
|
N95 mask material used to cover aperture of Hans Rudolph mask
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minute Ventilation
Time Frame: 15 minutes
|
Participants wore a tight fitting mask (Hans Rudolph) that was attached to the metabolic cart through an air sampling tube.
Inspired ambient air and expired air were channeled through a pneumotachometer that was attached to the front of the mask which calculated air volume by the rate of rotation of a rotor turbine located within it.
The turbine had zero resistance to air flow and the rate of rotation of the turbine, sensed by infrared light within the pneumotachometer, corresponds directly to inspired and expired air volume for each breath.
Multiple air samples from each expired-breath was drawn into the metabolic carts through a sampling line for the measurement of oxygen and carbon dioxide content by the respective gas sensors within the metabolic carts.
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen and carbon dioxide exchanged
Time Frame: 15 minutes
|
Participants wore a tight fitting mask (Hans Rudolph) that was attached to the metabolic cart through an air sampling tube.
Inspired ambient air and expired air were channeled through a pneumotachometer that was attached to the front of the mask which calculated air volume by the rate of rotation of a rotor turbine located within it.
The turbine had zero resistance to air flow and the rate of rotation of the turbine, sensed by infrared light within the pneumotachometer, corresponds directly to inspired and expired air volume for each breath.
Multiple air samples from each expired-breath was drawn into the metabolic carts through a sampling line for the measurement of oxygen and carbon dioxide content by the respective gas sensors within the metabolic carts.
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eu-Leong Yong, PhD, NUHS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
September 13, 2014
First Submitted That Met QC Criteria
October 15, 2014
First Posted (Estimate)
October 16, 2014
Study Record Updates
Last Update Posted (Estimate)
October 16, 2014
Last Update Submitted That Met QC Criteria
October 15, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010/00226
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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