Back to resultsRespiratory Consequences of N95-type Mask Usage in Pregnant Healthcare Workers - A Controlled Clinical Study
Primary Purpose
Hypoventilation
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
N95 mask
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypoventilation focused on measuring filtering facepiece respirators, N95 masks, pandemic response, pregnant healthcare workers
Eligibility Criteria
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.
Sites / Locations
- NUHS
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
N95
Arm Description
Intervention: N95 mask material
Outcomes
Primary Outcome Measures
Minute Ventilation
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.
Secondary Outcome Measures
Oxygen and carbon dioxide exchanged
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.
Full Information
NCT ID
NCT02265926
First Posted
September 13, 2014
Last Updated
October 15, 2014
Sponsor
National University Health System, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT02265926
Brief Title
Respiratory Consequences of N95-type Mask Usage in Pregnant Healthcare Workers - A Controlled Clinical Study
Official Title
Respiratory Consequences of N95-type Mask Usage in Pregnant Healthcare Workers - A Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Health System, Singapore
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoventilation
Keywords
filtering facepiece respirators, N95 masks, pandemic response, pregnant healthcare workers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N95
Arm Type
Experimental
Arm Description
Intervention: N95 mask material
Intervention Type
Device
Intervention Name(s)
N95 mask
Intervention Description
N95 mask material used to cover aperture of Hans Rudolph mask
Primary Outcome Measure Information:
Title
Minute Ventilation
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Oxygen and carbon dioxide exchanged
Description
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.
Time Frame
15 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eu-Leong Yong, PhD
Organizational Affiliation
NUHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
NUHS
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
Respiratory Consequences of N95-type Mask Usage in Pregnant Healthcare Workers - A Controlled Clinical Study
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