Respiratory Consequences of N95-type Mask Usage in Pregnant Healthcare Workers - A Controlled Clinical Study

Hypoventilation Clinical Trial

Official title:

Respiratory Consequences of N95-type Mask Usage in Pregnant Healthcare Workers - A Controlled Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265926
• Other study ID #: 2010/00226
• Status: Completed
• Phase: N/A
• First received: September 13, 2014
• Last updated: October 15, 2014
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2014
• Source: National University Health System, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypoventilation

Intervention

Device:
• N95 mask
N95 mask material used to cover aperture of Hans Rudolph mask

Locations

Country	Name	City	State
Singapore	NUHS	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Health System, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes	No
Secondary	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.	15 minutes	No