| Registry | NCT02265926 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, diagnostic |
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| Enrollment | 20 (Actual) |
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| Sponsor | National University Health System, Singapore (Other) |
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| Conditions | Hypoventilation |
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| Interventions | N95 mask (Device) |
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| Dates | start 2009-09-01, primary completion 2011-09-01, completion 2011-09-01, first posted 2014-10-16, last updated 2014-10-16 |
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| Locations | 1 site in Singapore |
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Related Papers Related Patents Related Grants Related Experts
All trials for Hypoventilation All trials of N95 mask
-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| N95 | Experimental | Device: N95 mask | Intervention: N95 mask material |
- N95 mask (Device): N95 mask material used to cover aperture of Hans Rudolph mask
+Outcome measures
Primary outcomes
- Minute Ventilation [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.
Secondary outcomes
- Oxygen and carbon dioxide exchanged [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.
+Eligibility
Sex: Female, ages: 21 Years to 40 Years
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.
+Locations (1)
| Facility | City | Country | Status |
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| NUHS | Singapore | Singapore | |
+Investigators