Face-masksNCT05193422
Protective Face Masks and Cardiopulmonary Parameters at Rest and During Exercise in Children
A study testing Spirometry - baseline, Spirometry - post CPET and Nasal peak inspiratory flow - baseline in people with Face-masks and Exercise, run by University of Patras.
Trial summary
This study will examine the possible effects of protective surgical masks on the cardiorespiratory function of children aged 8-14 years at rest and during exercise. The study will consist of two phases: Phase I: No face mask. 1. Measurement of peak nasal inspiratory flow 2. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Face-masks, Exercise
- What is being tested?
- Spirometry - baseline, Spirometry - post CPET and Nasal peak inspiratory flow - baseline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2022to 20 Mar 2022
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children should not suffer from conditions that are likely to affect CPET outcomes, such as respiratory (asthma and chronic lung disease), cardiac (congenital heart disease, heart failure), neurologic and musculoskeletal disorders.
- Height >135 cm
- Parental written informed consent
Who cannot join
- Points #1 or #2 not fulfilled
- Child not willing to participate (e.g. not willing to wear the sensors)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Protective Face Masks on Cardiopulmonary Parameters at Rest and During Exercise in Children
This study will examine the possible effects of protective surgical masks on the cardiorespiratory function of children aged 8-14 years at rest and during exercise.
The study will consist of two phases:
Read more
- Phase I: No face mask.
- Measurement of peak nasal inspiratory flow
- CPET with an ergometric bike at 30% of their predicted maximum workload (Wmax) for 4 minutes, 50% of Wmax for 2 minutes and 70% of Wmax for 1 minute, with continuous oxygen saturation (SpΟ2), heart rate (HR), end-tidal CO2 (EtCO2) and respiratory rate (RR) monitoring.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale
- Phase II: Face mask. Following nPIF measurement, participants will be asked to wear a standard surgical face mask. A temperature and humidity sensor will also be placed inside the mask. Will follow:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- CPET at 30% of Wmax for 4 minutes, 50% Wmax for 2 minutes and 70% Wmax for 1 minute. SpO2, HR, EtCO2 and RR will be continuously monitored.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
Both phases will be performed on the same day with a recovery phase of 30 minutes between them. Participants will be randomized to begin with Phase I followed by Phase II or Phase II followed by Phase I.
At both phases, SpO2, HR, EtCO2 and RR (10 s average values) will be recorder at each 1 minute during CPET, and at minutes 0, 3 and 6 during the resting phase of Phase II. During Phase II, temperature and humidity will also be recorded at each 1 minute during CPET and at minutes 0, 3 and 6 during the resting phase.
The total duration of the protocol is estimated at 90 minutes per participant. The study sample will consist of 40 children stratified by age.
Read the detailed description
PURPOSE
The purpose of this study is to investigate the possible effects of protective surgical masks on the cardiorespiratory function of children aged 8-14 years at rest and during exercise.
METHODS
- Population
Children aged 8-14 years (minimum height 135 cm) will be invited to participate. They will be recruited from the outpatient clinics of the Pediatric Allergy and Pediatric Endocrinology Departments of the University Hospital of Patras, Greece. Children should not suffer from conditions that are likely to affect cardiopulmonary exercise testing (CPET) outcomes, such as respiratory (asthma and chronic lung disease), cardiac (congenital heart disease, heart failure), neurologic and musculoskeletal disorders.
The parents of the children will be informed about the aims of the study and they will be asked to give written consent. The study has been approved by the local Research and Ethics Committee (Act no. 407/9.10.2020).
- Protocol
The study will be performed at the Respiratory Functions and CPET Laboratory of the Pediatric Pulmonary Unit. Children will present to the laboratory with one of their parents.
After history taking and measurement of weight and height, baseline spirometry will follow using a Micro5000 device (Medisoft, Sorinnes, Belgium) to determine FEV1, FVC, FEV1/FVC, FEF25-75 and PEF. The study will consist of two phases:
- Phase I: No face mask. Participants will perform
- Measurement of peak nasal inspiratory flow (nPIF) using the Micro5000 device and a specially modified nasal mask.
- CPET using an ULTIMA CPX device (MGC Diagnostics, Saint Paul, MI, USA) with an ergometric bike (eBike, GE Healthcare, Wauwatosa, WI, USA). Participants will be asked to exercise (steady pedaling at 60 rpm) at 30% of their predicted maximum workload (Wmax) for 4 minutes, at 50% of Wmax for 2 minutes and at 70% of Wmax for 1 minute. Wmax will be calculated as 3 Watts/kg. During CPET, oxygen saturation (SpΟ2) and heart rate (HR) will be continuously monitored using a Nonin 7500 pulse oximeter with a special ear sensor (Nonin Medical Inc, Plymouth, MN, USA). End-tidal CO2 (EtCO2) and respiratory rate (RR) will also be monitored using a Microstream device with special sampling (nasal) lines (Medtronic, Minneapolis, MN, USA).
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale graded from 1 to 10.
- Phase II: Face mask. Following nPIF measurement, participants will be asked to wear a standard surgical face mask. A temperature and humidity sensor (RHT03, MaxDetect Technologies, Shenzhen, China) will also be placed inside the mask on the right cheek, at nose level. Subsequently will follow:
- Resting phase, with the participants on the ergometric bike without pedaling and breathing normally for 6 minutes. SpO2, HR, EtCO2 and RR will be monitored during the resting phase.
- CPET at 30% of Wmax for 4 minutes, 50% of Wmax for 2 minutes and 70% of Wmax for 1 minute. SpO2, HR, EtCO2 and RR will be continuously monitored.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
Both phases will be performed on the same day with a recovery phase of 30 minutes between them. Participants will be randomized to begin with Phase I followed by Phase II or Phase II followed by Phase I.
At both phases, SpO2, HR, EtCO2 and RR (10 s average values) will be recorder at each 1 minute during CPET, and at minutes 0, 3 and 6 during the resting phase of Phase II. During Phase II, temperature and humidity will also be recorded at each 1 minute during CPET and at minutes 0, 3 and 6 during the resting phase.
The total duration of the protocol is estimated at 90 minutes per participant. The study sample will consist of 40 children stratified by age.
- Conditions
- Face-masks, Exercise
- Being tested
- Spirometry - baseline, Spirometry - post CPET, Nasal peak inspiratory flow - baseline, Nasal peak inspiratory flow - post CPET, Oxygen saturation
- Keywords
- face-masks, exercise, children
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirometry - baselineDiagnostic test
Standard spirometry using a Micro5000 spirometer to determine baseline FEV1, FVC, FEV1/FVC, FEF25-75 and PEF.
Baseline spirometry will be performed before CPET in both study arms
Spirometry - post CPETDiagnostic test
Standard spirometry using a Micro5000 spirometer to determine baseline % change in FEV1 after CPET and assess exercise-induced bronchoconstriction (defined as FEV1 decrease >10% at 5 minutes after CPET) Post spirometry will be performed after CPET in both study arms
Nasal peak inspiratory flow - baselineDiagnostic test
Measurement of peak nasal inspiratory flow (nPIF) using a Micro5000 spirometer and a specially modified nasal mask.
nPIF will be measured before CPET in both study arms
Nasal peak inspiratory flow - post CPETDiagnostic test
Measurement of peak nasal inspiratory flow (nPIF) using a Micro5000 spirometer and a specially modified nasal mask.
nPIF will be measured after CPET in both study arms
Oxygen saturationDiagnostic test
Also called SpO2
Continuous monitoring of SpO2 using a Nonin 7500 pulse oximeter, in both study arms
Heart RateDiagnostic test
Also called HR
Continuous monitoring of HR using a Nonin 7500 pulse oximeter, in both study arms
End-tidal CO2Diagnostic test
Also called EtCO2
Continuous monitoring of EtCO2 using a Microstream capnograph, in both study arms
Respiratory rateDiagnostic test
Also called RR
Continuous monitoring of RR using a Microstream capnograph, in both study arms
TemperatureDiagnostic test
Also called Temp
Continuous monitoring of Temp in the face mask using a RHT03 sensor, only in the experimental study arm
HumidityDiagnostic test
Also called Hum
Continuous monitoring of Hum in the face mask using a RHT03 sensor, only in the experimental study arm
Cardiopulmonary exercise testingDiagnostic test
Also called CPET
CPET using an ULTIMA CPX device (MGC Diagnostics, Saint Paul, MI, USA) with an ergometric bike (eBike, GE Healthcare, Wauwatosa, WI, USA). Participants will be asked to exercise (steady pedaling at 60 rpm) at 30% of their predicted maximum workload (Wmax) for 4 minutes, at 50% of Wmax for 2 minutes and at 70% of Wmax for 1 minute. Wmax will be calculated as 3 Watts/kg.
CPET will be performed in both study arms
Discomfort levelDiagnostic test
Discomfort assessment using a special scale graded from 1 to 10 (Fikenzer, 2020).
Both study arms, after CPET.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: No mask | Active comparator | Participants, without wearing a face mask, will undergo the following:
1. Measurement of peak nasal inspiratory flow
2. Cardiopulmonary exercise testing (CPET) with an ergometric bike at 30% of their predicted maximum workload (Wmax) for 4 minutes, 50% of Wmax for 2 minutes and 70% of Wmax for 1 minute, with continuous oxygen saturation (SpΟ2), heart rate (HR), end-tidal CO2 (EtCO2) and respiratory rate (RR) monitoring.
3. Spirometry and measurement of nPIF immediately after CPET.
4. Discomfort assessment using a special scale Receives: Diagnostic Test: Spirometry - baseline; Diagnostic Test: Spirometry - post CPET; Diagnostic Test: Nasal peak inspiratory flow - baseline; Diagnostic Test: Nasal peak inspiratory flow - post CPET; Diagnostic Test: Oxygen saturation; Diagnostic Test: Heart Rate; Diagnostic Test: End-tidal CO2; Diagnostic Test: Respiratory rate; Diagnostic Test: Cardiopulmonary exercise testing; Diagnostic Test: Discomfort level |
| Phase II: Face mask | Experimental | Following nPIF measurement, participants will be asked to wear a standard surgical face mask. A temperature and humidity sensor will also be placed inside the mask. Will follow:
1. Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
2. CPET at 30% of Wmax for 4 minutes, 50% Wmax for 2 minutes and 70% Wmax for 1 minute. SpO2, HR, EtCO2 and RR will be continuously monitored.
3. Spirometry and measurement of nPIF immediately after CPET.
4. Discomfort assessment. Receives: Diagnostic Test: Spirometry - post CPET; Diagnostic Test: Nasal peak inspiratory flow - baseline; Diagnostic Test: Nasal peak inspiratory flow - post CPET; Diagnostic Test: Oxygen saturation; Diagnostic Test: Heart Rate; Diagnostic Test: End-tidal CO2; Diagnostic Test: Respiratory rate; Diagnostic Test: Temperature; Diagnostic Test: Humidity; Diagnostic Test: Cardiopulmonary exercise testing; Diagnostic Test: Discomfort level |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2
Oxygen saturation
Measured: Minute 1
SpO2
Oxygen saturation
Measured: Minute 2
SpO2
Oxygen saturation
Measured: Minute 3
SpO2
Oxygen saturation
Measured: Minute 4
SpO2
Oxygen saturation
Measured: Minute 5
SpO2
Oxygen saturation
Measured: Minute 6
SpO2
Oxygen saturation
Measured: Minute 7
HR
Heart rate
Measured: Minute 1
HR
Heart rate
Measured: Minute 2
HR
Heart rate
Measured: Minute 3
HR
Heart rate
Measured: Minute 4
HR
Heart rate
Measured: Minute 5
HR
Heart rate
Measured: Minute 6
HR
Heart rate
Measured: Minute 7
EtCO2
End-tidal CO2
Measured: Minute 1
EtCO2
End-tidal CO2
Measured: Minute 2
EtCO2
End-tidal CO2
Measured: Minute 3
EtCO2
End-tidal CO2
Measured: Minute 4
EtCO2
End-tidal CO2
Measured: Minute 5
EtCO2
End-tidal CO2
Measured: Minute 6
EtCO2
End-tidal CO2
Measured: Minute 7
RR
Respiratory rate
Measured: Minute 1
RR
Respiratory rate
Measured: Minute 2
RR
Respiratory rate
Measured: Minute 3
RR
Respiratory rate
Measured: Minute 4
RR
Respiratory rate
Measured: Minute 5
RR
Respiratory rate
Measured: Minute 6
RR
Respiratory rate
Measured: Minute 7
Temperature
Air temperature (in degrees Celsius) within the face mask
Measured: Minute 1
Temperature
Air temperature (in degrees Celsius) within the face mask
Measured: Minute 2
Temperature
Air temperature (in degrees Celsius) within the face mask
Measured: Minute 3
Temperature
Air temperature (in degrees Celsius) within the face mask
Measured: Minutε 4
Temperature
Air temperature (in degrees Celsius) within the face mask
Measured: Minute 5
Temperature
Air temperature (in degrees Celsius) within the face mask
Measured: Minute 6
Temperature
Air temperature (in degrees Celsius) within the face mask
Measured: Minute 7
Humidity
Relative air humidity (%) within the face mask
Measured: Minute 1
Humidity
Relative air humidity (%) within the face mask
Measured: Minute 2
Humidity
Relative air humidity (%) within the face mask
Measured: Minute 3
Humidity
Relative air humidity (%) within the face mask
Measured: Minute 4
Humidity
Relative air humidity (%) within the face mask
Measured: Minute 5
Humidity
Relative air humidity (%) within the face mask
Measured: Minute 6
Humidity
Relative air humidity (%) within the face mask
Measured: Minute 7
Discomfort level
Level of discomfort (specific questionnaire (5 items), scale 1 to 10) after CPET
Measured: Minute 7
Exercise-induced bronchoconstriction
% change in FEV1 value before-after CPET
Measured: Minute 7
% change in nPIF
% change in nPIF value before-after CPET
Measured: Minute 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start20 Jan 2022 (estimated)
- Primary completion20 Feb 2022 (estimated)
- Study completion20 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Face-masksStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to begin with Phase I followed by Phase II or Phase II followed by Phase I.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fouzas Sotirios, University of Patras
- Investigators
- Sotirios Fouzas, Prof., Principal investigator, Pediatric Respiratory Unit, University Hospital of Patras, GreeceMichael Anthracopoulos, Prof., Study chair, Pediatric Respiratory Unit, University Hospital of Patras, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193422
- Sponsor's protocol ID
- 10092020
- Status last verified
- Jan 2022
- First submitted
- 3 Nov 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Protective Face Masks on Cardiopulmonary Parameters at Rest and During Exercise in Children
- ClinicalTrials.gov ID
- NCT05193422
- Acronym / sponsor ID
- 10092020
- Conditions
- Face-masks, Exercise
- Keywords
- face-masks, exercise, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- 20 Jan 2022 (estimated)
- Primary completion
- 20 Feb 2022 (estimated)
- Study completion
- 20 Mar 2022 (estimated)
- First posted
- 14 Jan 2022 (actual)
- 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.
This study will examine the possible effects of protective surgical masks on the cardiorespiratory function of children aged 8-14 years at rest and during exercise.
The study will consist of two phases:
- Phase I: No face mask.
- Measurement of peak nasal inspiratory flow
- CPET with an ergometric bike at 30% of their predicted maximum workload (Wmax) for 4 minutes, 50% of Wmax for 2 minutes and 70% of Wmax for 1 minute, with continuous oxygen saturation (SpΟ2), heart rate (HR), end-tidal CO2 (EtCO2) and respiratory rate (RR) monitoring.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale
- Phase II: Face mask. Following nPIF measurement, participants will be asked to wear a standard surgical face mask. A temperature and humidity sensor will also be placed inside the mask. Will follow:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- CPET at 30% of Wmax for 4 minutes, 50% Wmax for 2 minutes and 70% Wmax for 1 minute. SpO2, HR, EtCO2 and RR will be continuously monitored.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
Both phases will be performed on the same day with a recovery phase of 30 minutes between them. Participants will be randomized to begin with Phase I followed by Phase II or Phase II followed by Phase I.
At both phases, SpO2, HR, EtCO2 and RR (10 s average values) will be recorder at each 1 minute during CPET, and at minutes 0, 3 and 6 during the resting phase of Phase II. During Phase II, temperature and humidity will also be recorded at each 1 minute during CPET and at minutes 0, 3 and 6 during the resting phase.
The total duration of the protocol is estimated at 90 minutes per participant. The study sample will consist of 40 children stratified by age.
Detailed description
PURPOSE
The purpose of this study is to investigate the possible effects of protective surgical masks on the cardiorespiratory function of children aged 8-14 years at rest and during exercise.
METHODS
- Population
Children aged 8-14 years (minimum height 135 cm) will be invited to participate. They will be recruited from the outpatient clinics of the Pediatric Allergy and Pediatric Endocrinology Departments of the University Hospital of Patras, Greece. Children should not suffer from conditions that are likely to affect cardiopulmonary exercise testing (CPET) outcomes, such as respiratory (asthma and chronic lung disease), cardiac (congenital heart disease, heart failure), neurologic and musculoskeletal disorders.
The parents of the children will be informed about the aims of the study and they will be asked to give written consent. The study has been approved by the local Research and Ethics Committee (Act no. 407/9.10.2020).
- Protocol
The study will be performed at the Respiratory Functions and CPET Laboratory of the Pediatric Pulmonary Unit. Children will present to the laboratory with one of their parents.
After history taking and measurement of weight and height, baseline spirometry will follow using a Micro5000 device (Medisoft, Sorinnes, Belgium) to determine FEV1, FVC, FEV1/FVC, FEF25-75 and PEF. The study will consist of two phases:
- Phase I: No face mask. Participants will perform
- Measurement of peak nasal inspiratory flow (nPIF) using the Micro5000 device and a specially modified nasal mask.
- CPET using an ULTIMA CPX device (MGC Diagnostics, Saint Paul, MI, USA) with an ergometric bike (eBike, GE Healthcare, Wauwatosa, WI, USA). Participants will be asked to exercise (steady pedaling at 60 rpm) at 30% of their predicted maximum workload (Wmax) for 4 minutes, at 50% of Wmax for 2 minutes and at 70% of Wmax for 1 minute. Wmax will be calculated as 3 Watts/kg. During CPET, oxygen saturation (SpΟ2) and heart rate (HR) will be continuously monitored using a Nonin 7500 pulse oximeter with a special ear sensor (Nonin Medical Inc, Plymouth, MN, USA). End-tidal CO2 (EtCO2) and respiratory rate (RR) will also be monitored using a Microstream device with special sampling (nasal) lines (Medtronic, Minneapolis, MN, USA).
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale graded from 1 to 10.
- Phase II: Face mask. Following nPIF measurement, participants will be asked to wear a standard surgical face mask. A temperature and humidity sensor (RHT03, MaxDetect Technologies, Shenzhen, China) will also be placed inside the mask on the right cheek, at nose level. Subsequently will follow:
- Resting phase, with the participants on the ergometric bike without pedaling and breathing normally for 6 minutes. SpO2, HR, EtCO2 and RR will be monitored during the resting phase.
- CPET at 30% of Wmax for 4 minutes, 50% of Wmax for 2 minutes and 70% of Wmax for 1 minute. SpO2, HR, EtCO2 and RR will be continuously monitored.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
Both phases will be performed on the same day with a recovery phase of 30 minutes between them. Participants will be randomized to begin with Phase I followed by Phase II or Phase II followed by Phase I.
At both phases, SpO2, HR, EtCO2 and RR (10 s average values) will be recorder at each 1 minute during CPET, and at minutes 0, 3 and 6 during the resting phase of Phase II. During Phase II, temperature and humidity will also be recorded at each 1 minute during CPET and at minutes 0, 3 and 6 during the resting phase.
The total duration of the protocol is estimated at 90 minutes per participant. The study sample will consist of 40 children stratified by age.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to begin with Phase I followed by Phase II or Phase II followed by Phase I.
| Arm | Type | Receives |
|---|---|---|
| Phase I: No mask | Active comparator | Diagnostic Test: Spirometry - baseline, Diagnostic Test: Spirometry - post CPET, Diagnostic Test: Nasal peak inspiratory flow - baseline, Diagnostic Test: Nasal peak inspiratory flow - post CPET, Diagnostic Test: Oxygen saturation, Diagnostic Test: Heart Rate, Diagnostic Test: End-tidal CO2, Diagnostic Test: Respiratory rate, Diagnostic Test: Cardiopulmonary exercise testing, Diagnostic Test: Discomfort levelParticipants, without wearing a face mask, will undergo the following: 1. Measurement of peak nasal inspiratory flow 2. Cardiopulmonary exercise testing (CPET) with an ergometric bike at 30% of their predicted maximum workload (Wmax) for 4 minutes, 50% of Wmax for 2 minutes and 70% of Wmax for 1 minute, with continuous oxygen saturation (SpΟ2), heart rate (HR), end-tidal CO2 (EtCO2) and respiratory rate (RR) monitoring. 3. Spirometry and measurement of nPIF immediately after CPET. 4. Discomfort assessment using a special scale |
| Phase II: Face mask | Experimental | Diagnostic Test: Spirometry - post CPET, Diagnostic Test: Nasal peak inspiratory flow - baseline, Diagnostic Test: Nasal peak inspiratory flow - post CPET, Diagnostic Test: Oxygen saturation, Diagnostic Test: Heart Rate, Diagnostic Test: End-tidal CO2, Diagnostic Test: Respiratory rate, Diagnostic Test: Temperature, Diagnostic Test: Humidity, Diagnostic Test: Cardiopulmonary exercise testing, Diagnostic Test: Discomfort levelFollowing nPIF measurement, participants will be asked to wear a standard surgical face mask. A temperature and humidity sensor will also be placed inside the mask. Will follow: 1. Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored. 2. CPET at 30% of Wmax for 4 minutes, 50% Wmax for 2 minutes and 70% Wmax for 1 minute. SpO2, HR, EtCO2 and RR will be continuously monitored. 3. Spirometry and measurement of nPIF immediately after CPET. 4. Discomfort assessment. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children should not suffer from conditions that are likely to affect CPET outcomes, such as respiratory (asthma and chronic lung disease), cardiac (congenital heart disease, heart failure), neurologic and musculoskeletal disorders.
- Height >135 cm
- Parental written informed consent
Key exclusion criteria (2 listed)
- Points #1 or #2 not fulfilled
- Child not willing to participate (e.g. not willing to wear the sensors)
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 |
|---|---|---|
| Spirometry - baselineStandard spirometry using a Micro5000 spirometer to determine baseline FEV1, FVC, FEV1/FVC, FEF25-75 and PEF. Baseline spirometry will be performed before CPET in both study arms | Diagnostic test | Phase I: No mask |
| Spirometry - post CPETStandard spirometry using a Micro5000 spirometer to determine baseline % change in FEV1 after CPET and assess exercise-induced bronchoconstriction (defined as FEV1 decrease >10% at 5 minutes after CPET) Post spirometry will be performed after CPET in both study arms | Diagnostic test | Phase I: No mask, Phase II: Face mask |
| Nasal peak inspiratory flow - baselineMeasurement of peak nasal inspiratory flow (nPIF) using a Micro5000 spirometer and a specially modified nasal mask. nPIF will be measured before CPET in both study arms | Diagnostic test | Phase I: No mask, Phase II: Face mask |
| Nasal peak inspiratory flow - post CPETMeasurement of peak nasal inspiratory flow (nPIF) using a Micro5000 spirometer and a specially modified nasal mask. nPIF will be measured after CPET in both study arms | Diagnostic test | Phase I: No mask, Phase II: Face mask |
| Oxygen saturationAlso: SpO2Continuous monitoring of SpO2 using a Nonin 7500 pulse oximeter, in both study arms | Diagnostic test | Phase I: No mask, Phase II: Face mask |
| Heart RateAlso: HRContinuous monitoring of HR using a Nonin 7500 pulse oximeter, in both study arms | Diagnostic test | Phase I: No mask, Phase II: Face mask |
| End-tidal CO2Also: EtCO2Continuous monitoring of EtCO2 using a Microstream capnograph, in both study arms | Diagnostic test | Phase I: No mask, Phase II: Face mask |
| Respiratory rateAlso: RRContinuous monitoring of RR using a Microstream capnograph, in both study arms | Diagnostic test | Phase I: No mask, Phase II: Face mask |
| TemperatureAlso: TempContinuous monitoring of Temp in the face mask using a RHT03 sensor, only in the experimental study arm | Diagnostic test | Phase II: Face mask |
| HumidityAlso: HumContinuous monitoring of Hum in the face mask using a RHT03 sensor, only in the experimental study arm | Diagnostic test | Phase II: Face mask |
| Cardiopulmonary exercise testingAlso: CPETCPET using an ULTIMA CPX device (MGC Diagnostics, Saint Paul, MI, USA) with an ergometric bike (eBike, GE Healthcare, Wauwatosa, WI, USA). Participants will be asked to exercise (steady pedaling at 60 rpm) at 30% of their predicted maximum workload (Wmax) for 4 minutes, at 50% of Wmax for 2 minutes and at 70% of Wmax for 1 minute. Wmax will be calculated as 3 Watts/kg. CPET will be performed in both study arms | Diagnostic test | Phase I: No mask, Phase II: Face mask |
| Discomfort levelDiscomfort assessment using a special scale graded from 1 to 10 (Fikenzer, 2020). Both study arms, after CPET. | Diagnostic test | Phase I: No mask, Phase II: Face mask |
Primary outcome
SpO2
Time frame: Minute 1
Oxygen saturation
SpO2
Time frame: Minute 2
Oxygen saturation
SpO2
Time frame: Minute 3
Oxygen saturation
SpO2
Time frame: Minute 4
Oxygen saturation
SpO2
Time frame: Minute 5
Oxygen saturation
SpO2
Time frame: Minute 6
Oxygen saturation
SpO2
Time frame: Minute 7
Oxygen saturation
HR
Time frame: Minute 1
Heart rate
HR
Time frame: Minute 2
Heart rate
HR
Time frame: Minute 3
Heart rate
HR
Time frame: Minute 4
Heart rate
HR
Time frame: Minute 5
Heart rate
HR
Time frame: Minute 6
Heart rate
HR
Time frame: Minute 7
Heart rate
EtCO2
Time frame: Minute 1
End-tidal CO2
EtCO2
Time frame: Minute 2
End-tidal CO2
EtCO2
Time frame: Minute 3
End-tidal CO2
EtCO2
Time frame: Minute 4
End-tidal CO2
EtCO2
Time frame: Minute 5
End-tidal CO2
EtCO2
Time frame: Minute 6
End-tidal CO2
EtCO2
Time frame: Minute 7
End-tidal CO2
RR
Time frame: Minute 1
Respiratory rate
RR
Time frame: Minute 2
Respiratory rate
RR
Time frame: Minute 3
Respiratory rate
RR
Time frame: Minute 4
Respiratory rate
RR
Time frame: Minute 5
Respiratory rate
RR
Time frame: Minute 6
Respiratory rate
RR
Time frame: Minute 7
Respiratory rate
Temperature
Time frame: Minute 1
Air temperature (in degrees Celsius) within the face mask
Temperature
Time frame: Minute 2
Air temperature (in degrees Celsius) within the face mask
Temperature
Time frame: Minute 3
Air temperature (in degrees Celsius) within the face mask
Temperature
Time frame: Minutε 4
Air temperature (in degrees Celsius) within the face mask
Temperature
Time frame: Minute 5
Air temperature (in degrees Celsius) within the face mask
Temperature
Time frame: Minute 6
Air temperature (in degrees Celsius) within the face mask
Temperature
Time frame: Minute 7
Air temperature (in degrees Celsius) within the face mask
Humidity
Time frame: Minute 1
Relative air humidity (%) within the face mask
Humidity
Time frame: Minute 2
Relative air humidity (%) within the face mask
Humidity
Time frame: Minute 3
Relative air humidity (%) within the face mask
Humidity
Time frame: Minute 4
Relative air humidity (%) within the face mask
Humidity
Time frame: Minute 5
Relative air humidity (%) within the face mask
Humidity
Time frame: Minute 6
Relative air humidity (%) within the face mask
Humidity
Time frame: Minute 7
Relative air humidity (%) within the face mask
Discomfort level
Time frame: Minute 7
Level of discomfort (specific questionnaire (5 items), scale 1 to 10) after CPET
Exercise-induced bronchoconstriction
Time frame: Minute 7
% change in FEV1 value before-after CPET
% change in nPIF
Time frame: Minute 7
% change in nPIF value before-after CPET
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
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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.
Sotirios Fouzas, Prof. principal investigator
Pediatric Respiratory Unit, University Hospital of Patras, Greece
Michael Anthracopoulos, Prof. study chair
Pediatric Respiratory Unit, University Hospital of Patras, Greece
Questions about this trial
What is this clinical trial studying?
A study testing Spirometry - baseline, Spirometry - post CPET and Nasal peak inspiratory flow - baseline in people with Face-masks and Exercise, run by University of Patras.
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 3 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: status not confirmed, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sotirios Fouzas, Prof. (+30 6944510047, sfouzas@upatras.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 (time frame: Minute 1). The study lists 45 primary outcomes in all. 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 14 Jan 2022.