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

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. 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.

Conditions

• Face-masks
• Exercise

Interventions

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

DIAGNOSTIC_TEST

Heart Rate

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

DIAGNOSTIC_TEST

End-tidal CO2

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

DIAGNOSTIC_TEST

Respiratory rate

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

DIAGNOSTIC_TEST

Temperature

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

DIAGNOSTIC_TEST

Humidity

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

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

DIAGNOSTIC_TEST

Discomfort level

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

Sponsors & Collaborators

• University of Patras

  lead OTHER

Principal Investigators

• Sotirios Fouzas, Prof. · Pediatric Respiratory Unit, University Hospital of Patras, Greece

• Michael Anthracopoulos, Prof. · Pediatric Respiratory Unit, University Hospital of Patras, Greece

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

8 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-01-20

Primary Completion

2022-02-20

Completion

2022-03-20