NCT05193422

Brief 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:

  1. 1.Measurement of peak nasal inspiratory flow
  2. 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. 3.Spirometry and measurement of nPIF immediately after CPET.
  4. 4.Discomfort assessment using a special scale
  5. 5.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:
  6. 6.Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
  7. 7.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.
  8. 8.Spirometry and measurement of nPIF immediately after CPET.
  9. 9.Discomfort assessment.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

January 20, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

1 month

First QC Date

November 3, 2021

Last Update Submit

January 1, 2022

Conditions

Face-masksExercise

Keywords

face-masksexercisechildren

Outcome Measures

Primary Outcomes (45)

  • SpO2

    Oxygen saturation

    Minute 1

  • SpO2

    Oxygen saturation

    Minute 2

  • SpO2

    Oxygen saturation

    Minute 3

  • SpO2

    Oxygen saturation

    Minute 4

  • SpO2

    Oxygen saturation

    Minute 5

  • SpO2

    Oxygen saturation

    Minute 6

  • SpO2

    Oxygen saturation

    Minute 7

  • HR

    Heart rate

    Minute 1

  • HR

    Heart rate

    Minute 2

  • HR

    Heart rate

    Minute 3

  • HR

    Heart rate

    Minute 4

  • HR

    Heart rate

    Minute 5

  • HR

    Heart rate

    Minute 6

  • HR

    Heart rate

    Minute 7

  • EtCO2

    End-tidal CO2

    Minute 1

  • EtCO2

    End-tidal CO2

    Minute 2

  • EtCO2

    End-tidal CO2

    Minute 3

  • EtCO2

    End-tidal CO2

    Minute 4

  • EtCO2

    End-tidal CO2

    Minute 5

  • EtCO2

    End-tidal CO2

    Minute 6

  • EtCO2

    End-tidal CO2

    Minute 7

  • RR

    Respiratory rate

    Minute 1

  • RR

    Respiratory rate

    Minute 2

  • RR

    Respiratory rate

    Minute 3

  • RR

    Respiratory rate

    Minute 4

  • RR

    Respiratory rate

    Minute 5

  • RR

    Respiratory rate

    Minute 6

  • RR

    Respiratory rate

    Minute 7

  • Temperature

    Air temperature (in degrees Celsius) within the face mask

    Minute 1

  • Temperature

    Air temperature (in degrees Celsius) within the face mask

    Minute 2

  • Temperature

    Air temperature (in degrees Celsius) within the face mask

    Minute 3

  • Temperature

    Air temperature (in degrees Celsius) within the face mask

    Minutε 4

  • Temperature

    Air temperature (in degrees Celsius) within the face mask

    Minute 5

  • Temperature

    Air temperature (in degrees Celsius) within the face mask

    Minute 6

  • Temperature

    Air temperature (in degrees Celsius) within the face mask

    Minute 7

  • Humidity

    Relative air humidity (%) within the face mask

    Minute 1

  • Humidity

    Relative air humidity (%) within the face mask

    Minute 2

  • Humidity

    Relative air humidity (%) within the face mask

    Minute 3

  • Humidity

    Relative air humidity (%) within the face mask

    Minute 4

  • Humidity

    Relative air humidity (%) within the face mask

    Minute 5

  • Humidity

    Relative air humidity (%) within the face mask

    Minute 6

  • Humidity

    Relative air humidity (%) within the face mask

    Minute 7

  • Discomfort level

    Level of discomfort (specific questionnaire (5 items), scale 1 to 10) after CPET

    Minute 7

  • Exercise-induced bronchoconstriction

    % change in FEV1 value before-after CPET

    Minute 7

  • % change in nPIF

    % change in nPIF value before-after CPET

    Minute 7

Study Arms (2)

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

Diagnostic Test: Spirometry - baselineDiagnostic Test: Spirometry - post CPETDiagnostic Test: Nasal peak inspiratory flow - baselineDiagnostic Test: Nasal peak inspiratory flow - post CPETDiagnostic Test: Oxygen saturationDiagnostic Test: Heart RateDiagnostic Test: End-tidal CO2Diagnostic Test: Respiratory rateDiagnostic Test: Cardiopulmonary exercise testingDiagnostic 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.

Diagnostic Test: Spirometry - post CPETDiagnostic Test: Nasal peak inspiratory flow - baselineDiagnostic Test: Nasal peak inspiratory flow - post CPETDiagnostic Test: Oxygen saturationDiagnostic Test: Heart RateDiagnostic Test: End-tidal CO2Diagnostic Test: Respiratory rateDiagnostic Test: TemperatureDiagnostic Test: HumidityDiagnostic Test: Cardiopulmonary exercise testingDiagnostic Test: Discomfort level

Interventions

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

Phase I: No mask
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

Phase I: No maskPhase II: Face mask
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

Phase I: No maskPhase II: Face mask
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

Phase I: No maskPhase II: Face mask
Oxygen saturationDIAGNOSTIC_TEST

Continuous monitoring of SpO2 using a Nonin 7500 pulse oximeter, in both study arms

Also known as: SpO2
Phase I: No maskPhase II: Face mask
Heart RateDIAGNOSTIC_TEST

Continuous monitoring of HR using a Nonin 7500 pulse oximeter, in both study arms

Also known as: HR
Phase I: No maskPhase II: Face mask
End-tidal CO2DIAGNOSTIC_TEST

Continuous monitoring of EtCO2 using a Microstream capnograph, in both study arms

Also known as: EtCO2
Phase I: No maskPhase II: Face mask
Respiratory rateDIAGNOSTIC_TEST

Continuous monitoring of RR using a Microstream capnograph, in both study arms

Also known as: RR
Phase I: No maskPhase II: Face mask
TemperatureDIAGNOSTIC_TEST

Continuous monitoring of Temp in the face mask using a RHT03 sensor, only in the experimental study arm

Also known as: Temp
Phase II: Face mask
HumidityDIAGNOSTIC_TEST

Continuous monitoring of Hum in the face mask using a RHT03 sensor, only in the experimental study arm

Also known as: Hum
Phase II: Face mask
Cardiopulmonary exercise testingDIAGNOSTIC_TEST

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

Also known as: CPET
Phase I: No maskPhase II: Face mask
Discomfort levelDIAGNOSTIC_TEST

Discomfort assessment using a special scale graded from 1 to 10 (Fikenzer, 2020). Both study arms, after CPET.

Phase I: No maskPhase II: Face mask

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Interventions

Oxygen SaturationHeart RateRespiratory RateTemperatureBody TemperatureHumidityExercise Test

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

MetabolismVital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaRespirationRespiratory Physiological PhenomenaThermodynamicsPhysical PhenomenaWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment, ControlledEnvironment and Public HealthPhysiological PhenomenaHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Sotirios Fouzas, Prof.

    Pediatric Respiratory Unit, University Hospital of Patras, Greece

    PRINCIPAL INVESTIGATOR

  • Michael Anthracopoulos, Prof.

    Pediatric Respiratory Unit, University Hospital of Patras, Greece

    STUDY CHAIR

Central Study Contacts

Sotirios Fouzas, Prof.

CONTACT

+30 6944510047sfouzas@upatras.gr

Michael Anthracopoulos, Prof.

CONTACT

+30 2610 999716manthra@otenet.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Participants will be randomized to begin with Phase I followed by Phase II or Phase II followed by Phase I.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

November 3, 2021

First Posted

January 14, 2022

Study Start

January 20, 2022

Primary Completion

February 20, 2022

Study Completion

March 20, 2022

Last Updated

January 14, 2022

Record last verified: 2022-01