HypoventilationNCT02265926
Respiratory Consequences of N95-type Mask Usage in Pregnant Healthcare Workers - A Controlled Clinical Study
A study testing N95 mask in people with Hypoventilation, run by National University Health System, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Hypoventilation
- What is being tested?
- N95 mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects had spontaneously conceived singleton pregnancies and were between 21 to 40 years old. Their hemoglobin levels were ≥11g/dL
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypoventilation
- Being tested
- N95 mask
- Keywords
- filtering facepiece respirators, N95 masks, pandemic response, pregnant healthcare workers
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N95 maskDevice
N95 mask material used to cover aperture of Hans Rudolph mask
| Study group | Role | What they receive |
|---|---|---|
| N95 | Experimental | Intervention: N95 mask material Receives: Device: N95 mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Secondary outcomes (1)
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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoventilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pearl Tong, National University Health System, Singapore
- Investigators
- Eu-Leong Yong, PhD, Principal investigator, NUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265926
- Sponsor's protocol ID
- 2010/00226
- Status last verified
- Oct 2014
- First submitted
- 13 Sep 2014
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Consequences of N95-type Mask Usage in Pregnant Healthcare Workers - A Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT02265926
- Acronym / sponsor ID
- 2010/00226
- Conditions
- Hypoventilation
- Keywords
- filtering facepiece respirators, N95 masks, pandemic response, pregnant healthcare workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N95 | Experimental | Device: N95 maskIntervention: N95 mask material |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects had spontaneously conceived singleton pregnancies and were between 21 to 40 years old. Their hemoglobin levels were ≥11g/dL
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N95 maskN95 mask material used to cover aperture of Hans Rudolph mask | Device | N95 |
Primary outcome
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.
1 secondary outcome
Oxygen and carbon dioxide exchanged
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
Related trials for Hypoventilation
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Recruiting
Assessing the Acute Effects of Virtual Reality Interventions on Stress
Slow Breathing
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Recruiting
Effects of Controlled Breathing Added to Therapeutic Exercise in Multiple Myeloma
Multiple Myeloma, Breathing Techniques
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eu-Leong Yong, PhD principal investigator
NUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N95 mask in people with Hypoventilation, run by National University Health System, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minute Ventilation (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.