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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05193422
Other study ID # 10092020
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 20, 2022
Est. completion date March 20, 2022

Study information

Verified date January 2022
Source University of Patras
Contact Sotirios Fouzas, Prof.
Phone +30 6944510047
Email sfouzas@upatras.gr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date March 20, 2022
Est. primary completion date February 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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
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
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
Oxygen saturation
Continuous monitoring of SpO2 using a Nonin 7500 pulse oximeter, in both study arms
Heart Rate
Continuous monitoring of HR using a Nonin 7500 pulse oximeter, in both study arms
End-tidal CO2
Continuous monitoring of EtCO2 using a Microstream capnograph, in both study arms
Respiratory rate
Continuous monitoring of RR using a Microstream capnograph, in both study arms
Temperature
Continuous monitoring of Temp in the face mask using a RHT03 sensor, only in the experimental study arm
Humidity
Continuous monitoring of Hum in the face mask using a RHT03 sensor, only in the experimental study arm
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
Discomfort level
Discomfort assessment using a special scale graded from 1 to 10 (Fikenzer, 2020). Both study arms, after CPET.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Patras

Outcome

Type Measure Description Time frame Safety issue
Primary SpO2 Oxygen saturation Minute 1
Primary SpO2 Oxygen saturation Minute 2
Primary SpO2 Oxygen saturation Minute 3
Primary SpO2 Oxygen saturation Minute 4
Primary SpO2 Oxygen saturation Minute 5
Primary SpO2 Oxygen saturation Minute 6
Primary SpO2 Oxygen saturation Minute 7
Primary HR Heart rate Minute 1
Primary HR Heart rate Minute 2
Primary HR Heart rate Minute 3
Primary HR Heart rate Minute 4
Primary HR Heart rate Minute 5
Primary HR Heart rate Minute 6
Primary HR Heart rate Minute 7
Primary EtCO2 End-tidal CO2 Minute 1
Primary EtCO2 End-tidal CO2 Minute 2
Primary EtCO2 End-tidal CO2 Minute 3
Primary EtCO2 End-tidal CO2 Minute 4
Primary EtCO2 End-tidal CO2 Minute 5
Primary EtCO2 End-tidal CO2 Minute 6
Primary EtCO2 End-tidal CO2 Minute 7
Primary RR Respiratory rate Minute 1
Primary RR Respiratory rate Minute 2
Primary RR Respiratory rate Minute 3
Primary RR Respiratory rate Minute 4
Primary RR Respiratory rate Minute 5
Primary RR Respiratory rate Minute 6
Primary RR Respiratory rate Minute 7
Primary Temperature Air temperature (in degrees Celsius) within the face mask Minute 1
Primary Temperature Air temperature (in degrees Celsius) within the face mask Minute 2
Primary Temperature Air temperature (in degrees Celsius) within the face mask Minute 3
Primary Temperature Air temperature (in degrees Celsius) within the face mask Minute 4
Primary Temperature Air temperature (in degrees Celsius) within the face mask Minute 5
Primary Temperature Air temperature (in degrees Celsius) within the face mask Minute 6
Primary Temperature Air temperature (in degrees Celsius) within the face mask Minute 7
Primary Humidity Relative air humidity (%) within the face mask Minute 1
Primary Humidity Relative air humidity (%) within the face mask Minute 2
Primary Humidity Relative air humidity (%) within the face mask Minute 3
Primary Humidity Relative air humidity (%) within the face mask Minute 4
Primary Humidity Relative air humidity (%) within the face mask Minute 5
Primary Humidity Relative air humidity (%) within the face mask Minute 6
Primary Humidity Relative air humidity (%) within the face mask Minute 7
Primary Discomfort level Level of discomfort (specific questionnaire (5 items), scale 1 to 10) after CPET Minute 7
Primary Exercise-induced bronchoconstriction % change in FEV1 value before-after CPET Minute 7
Primary % change in nPIF % change in nPIF value before-after CPET Minute 7
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