Protective Face Masks and Cardiopulmonary Parameters at Rest and During Exercise in Children

January 1, 2022 updated by: Fouzas Sotirios, University of Patras

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:

  • Phase I: No face mask.

    1. Measurement of peak nasal inspiratory flow
    2. 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. 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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

A. 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).

B. 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

    1. Measurement of peak nasal inspiratory flow (nPIF) using the Micro5000 device and a specially modified nasal mask.

    2. 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).

    3. Spirometry and measurement of nPIF immediately after CPET.
    4. 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:

    1. 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.
    2. 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.
    3. Spirometry and measurement of nPIF immediately after CPET.
    4. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Michael Anthracopoulos, Prof.
  • Phone Number: +30 2610 999716
  • Email: manthra@otenet.gr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Height >135 cm
  3. Parental written informed consent

Exclusion Criteria:

  1. Points #1 or #2 not fulfilled
  2. Child not willing to participate (e.g. not willing to wear the sensors)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Phase I: No mask

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
Diagnostic test: Spirometry - baseline

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

Diagnostic test: Spirometry - post CPET
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
Diagnostic test: Nasal peak inspiratory flow - baseline

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

Diagnostic test: Nasal peak inspiratory flow - post CPET

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

Diagnostic test: Oxygen saturation
Continuous monitoring of SpO2 using a Nonin 7500 pulse oximeter, in both study arms
Other Names:
  • SpO2
Diagnostic test: Heart Rate
Continuous monitoring of HR using a Nonin 7500 pulse oximeter, in both study arms
Other Names:
  • HR
Diagnostic test: End-tidal CO2
Continuous monitoring of EtCO2 using a Microstream capnograph, in both study arms
Other Names:
  • EtCO2
Diagnostic test: Respiratory rate
Continuous monitoring of RR using a Microstream capnograph, in both study arms
Other Names:
  • RR
Diagnostic test: Cardiopulmonary exercise testing

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

Other Names:
  • CPET
Diagnostic test: Discomfort level

Discomfort assessment using a special scale graded from 1 to 10 (Fikenzer, 2020).

Both study arms, after CPET.
Experimental: 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:

  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.
Diagnostic test: Spirometry - post CPET
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
Diagnostic test: Nasal peak inspiratory flow - baseline

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

Diagnostic test: Nasal peak inspiratory flow - post CPET

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

Diagnostic test: Oxygen saturation
Continuous monitoring of SpO2 using a Nonin 7500 pulse oximeter, in both study arms
Other Names:
  • SpO2
Diagnostic test: Heart Rate
Continuous monitoring of HR using a Nonin 7500 pulse oximeter, in both study arms
Other Names:
  • HR
Diagnostic test: End-tidal CO2
Continuous monitoring of EtCO2 using a Microstream capnograph, in both study arms
Other Names:
  • EtCO2
Diagnostic test: Respiratory rate
Continuous monitoring of RR using a Microstream capnograph, in both study arms
Other Names:
  • RR
Diagnostic test: Cardiopulmonary exercise testing

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

Other Names:
  • CPET
Diagnostic test: Discomfort level

Discomfort assessment using a special scale graded from 1 to 10 (Fikenzer, 2020).

Both study arms, after CPET.

Diagnostic test: Temperature
Continuous monitoring of Temp in the face mask using a RHT03 sensor, only in the experimental study arm
Other Names:
  • Temp
Diagnostic test: Humidity
Continuous monitoring of Hum in the face mask using a RHT03 sensor, only in the experimental study arm
Other Names:
  • Hum

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SpO2
Time Frame: Minute 1
Oxygen saturation
Minute 1
SpO2
Time Frame: Minute 2
Oxygen saturation
Minute 2
SpO2
Time Frame: Minute 3
Oxygen saturation
Minute 3
SpO2
Time Frame: Minute 4
Oxygen saturation
Minute 4
SpO2
Time Frame: Minute 5
Oxygen saturation
Minute 5
SpO2
Time Frame: Minute 6
Oxygen saturation
Minute 6
SpO2
Time Frame: Minute 7
Oxygen saturation
Minute 7
HR
Time Frame: Minute 1
Heart rate
Minute 1
HR
Time Frame: Minute 2
Heart rate
Minute 2
HR
Time Frame: Minute 3
Heart rate
Minute 3
HR
Time Frame: Minute 4
Heart rate
Minute 4
HR
Time Frame: Minute 5
Heart rate
Minute 5
HR
Time Frame: Minute 6
Heart rate
Minute 6
HR
Time Frame: Minute 7
Heart rate
Minute 7
EtCO2
Time Frame: Minute 1
End-tidal CO2
Minute 1
EtCO2
Time Frame: Minute 2
End-tidal CO2
Minute 2
EtCO2
Time Frame: Minute 3
End-tidal CO2
Minute 3
EtCO2
Time Frame: Minute 4
End-tidal CO2
Minute 4
EtCO2
Time Frame: Minute 5
End-tidal CO2
Minute 5
EtCO2
Time Frame: Minute 6
End-tidal CO2
Minute 6
EtCO2
Time Frame: Minute 7
End-tidal CO2
Minute 7
RR
Time Frame: Minute 1
Respiratory rate
Minute 1
RR
Time Frame: Minute 2
Respiratory rate
Minute 2
RR
Time Frame: Minute 3
Respiratory rate
Minute 3
RR
Time Frame: Minute 4
Respiratory rate
Minute 4
RR
Time Frame: Minute 5
Respiratory rate
Minute 5
RR
Time Frame: Minute 6
Respiratory rate
Minute 6
RR
Time Frame: Minute 7
Respiratory rate
Minute 7
Temperature
Time Frame: Minute 1
Air temperature (in degrees Celsius) within the face mask
Minute 1
Temperature
Time Frame: Minute 2
Air temperature (in degrees Celsius) within the face mask
Minute 2
Temperature
Time Frame: Minute 3
Air temperature (in degrees Celsius) within the face mask
Minute 3
Temperature
Time Frame: Minutε 4
Air temperature (in degrees Celsius) within the face mask
Minutε 4
Temperature
Time Frame: Minute 5
Air temperature (in degrees Celsius) within the face mask
Minute 5
Temperature
Time Frame: Minute 6
Air temperature (in degrees Celsius) within the face mask
Minute 6
Temperature
Time Frame: Minute 7
Air temperature (in degrees Celsius) within the face mask
Minute 7
Humidity
Time Frame: Minute 1
Relative air humidity (%) within the face mask
Minute 1
Humidity
Time Frame: Minute 2
Relative air humidity (%) within the face mask
Minute 2
Humidity
Time Frame: Minute 3
Relative air humidity (%) within the face mask
Minute 3
Humidity
Time Frame: Minute 4
Relative air humidity (%) within the face mask
Minute 4
Humidity
Time Frame: Minute 5
Relative air humidity (%) within the face mask
Minute 5
Humidity
Time Frame: Minute 6
Relative air humidity (%) within the face mask
Minute 6
Humidity
Time Frame: Minute 7
Relative air humidity (%) within the face mask
Minute 7
Discomfort level
Time Frame: Minute 7
Level of discomfort (specific questionnaire (5 items), scale 1 to 10) after CPET
Minute 7
Exercise-induced bronchoconstriction
Time Frame: Minute 7
% change in FEV1 value before-after CPET
Minute 7
% change in nPIF
Time Frame: Minute 7
% change in nPIF value before-after CPET
Minute 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Patras

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sotirios Fouzas, Prof., Pediatric Respiratory Unit, University Hospital of Patras, Greece
  • Study Chair: Michael Anthracopoulos, Prof., Pediatric Respiratory Unit, University Hospital of Patras, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10092020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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