Ignite Creation Date:
2024-05-06 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05193422
Status:
UNKNOWN
Last Update Posted:
2022-01-14
First Post:
2021-11-03
Brief Title:
Protective Face Masks and Cardiopulmonary Parameters at Rest and During Exercise in Children
Sponsor:
University of Patras
Organization:
University of Patras
Study Overview
Official Title:
Effects of Protective Face Masks on Cardiopulmonary Parameters at Rest and During Exercise in Children
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 4079102020
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 FEV1FVC 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 Wattskg
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
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 4079102020
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 FEV1FVC 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 Wattskg
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None