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

N

National University Health System, Singapore

Status

Completed

Conditions

Hypoventilation

Treatments

Device: N95 mask

Study type

Interventional

Funder types

Other

Identifiers

NCT02265926
2010/00226

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

Female

Ages

21 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

N95
Experimental group
Description:
Intervention: N95 mask material
Treatment:
Device: N95 mask

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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