Effects of Protective Face Masks on Cardiopulmonary Parameters at Rest and During Exercise in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Temperature
研究概览
简要总结
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.
- Measurement of peak nasal inspiratory flow
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- 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:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Points #1 or #2 not fulfilled
- •Child not willing to participate (e.g. not willing to wear the sensors)
研究组 & 干预措施
Phase I: No mask
Participants, without wearing a face mask, will undergo the following:
- Measurement of peak nasal inspiratory flow
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale
干预措施: Spirometry - baseline (Diagnostic Test)
Phase I: No mask
Participants, without wearing a face mask, will undergo the following:
- Measurement of peak nasal inspiratory flow
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale
干预措施: Spirometry - post CPET (Diagnostic Test)
Phase I: No mask
Participants, without wearing a face mask, will undergo the following:
- Measurement of peak nasal inspiratory flow
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale
干预措施: Nasal peak inspiratory flow - baseline (Diagnostic Test)
Phase I: No mask
Participants, without wearing a face mask, will undergo the following:
- Measurement of peak nasal inspiratory flow
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale
干预措施: Oxygen saturation (Diagnostic Test)
Phase I: No mask
Participants, without wearing a face mask, will undergo the following:
- Measurement of peak nasal inspiratory flow
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale
干预措施: Nasal peak inspiratory flow - post CPET (Diagnostic Test)
Phase I: No mask
Participants, without wearing a face mask, will undergo the following:
- Measurement of peak nasal inspiratory flow
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale
干预措施: Heart Rate (Diagnostic Test)
Phase I: No mask
Participants, without wearing a face mask, will undergo the following:
- Measurement of peak nasal inspiratory flow
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale
干预措施: End-tidal CO2 (Diagnostic Test)
Phase I: No mask
Participants, without wearing a face mask, will undergo the following:
- Measurement of peak nasal inspiratory flow
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale
干预措施: Respiratory rate (Diagnostic Test)
Phase I: No mask
Participants, without wearing a face mask, will undergo the following:
- Measurement of peak nasal inspiratory flow
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale
干预措施: Cardiopulmonary exercise testing (Diagnostic Test)
Phase I: No mask
Participants, without wearing a face mask, will undergo the following:
- Measurement of peak nasal inspiratory flow
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment using a special scale
干预措施: Discomfort level (Diagnostic Test)
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:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
干预措施: Spirometry - post CPET (Diagnostic Test)
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:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
干预措施: Nasal peak inspiratory flow - baseline (Diagnostic Test)
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:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
干预措施: Nasal peak inspiratory flow - post CPET (Diagnostic Test)
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:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
干预措施: Oxygen saturation (Diagnostic Test)
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:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
干预措施: Heart Rate (Diagnostic Test)
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:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
干预措施: End-tidal CO2 (Diagnostic Test)
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:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
干预措施: Respiratory rate (Diagnostic Test)
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:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
干预措施: Temperature (Diagnostic Test)
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:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
干预措施: Humidity (Diagnostic Test)
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:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
干预措施: Cardiopulmonary exercise testing (Diagnostic Test)
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:
- Resting phase, 6 minutes. SpO2, HR, EtCO2 and RR will be monitored.
- 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.
- Spirometry and measurement of nPIF immediately after CPET.
- Discomfort assessment.
干预措施: Discomfort level (Diagnostic Test)
结局指标
主要结局
Temperature
时间窗: Minute 7
Air temperature (in degrees Celsius) within the face mask
Humidity
时间窗: Minute 7
Relative air humidity (%) within the face mask
EtCO2
时间窗: Minute 7
End-tidal CO2
Exercise-induced bronchoconstriction
时间窗: Minute 7
% change in FEV1 value before-after CPET
RR
时间窗: Minute 7
Respiratory rate
HR
时间窗: Minute 7
Heart rate
% change in nPIF
时间窗: Minute 7
% change in nPIF value before-after CPET
SpO2
时间窗: Minute 7
Oxygen saturation
Discomfort level
时间窗: Minute 7
Level of discomfort (specific questionnaire (5 items), scale 1 to 10) after CPET
HR
时间窗: Minute 4
Heart rate
HR
时间窗: Minute 5
Heart rate
HR
时间窗: Minute 6
Heart rate
EtCO2
时间窗: Minute 1
End-tidal CO2
EtCO2
时间窗: Minute 2
End-tidal CO2
EtCO2
时间窗: Minute 3
End-tidal CO2
EtCO2
时间窗: Minute 4
End-tidal CO2
SpO2
时间窗: Minute 1
Oxygen saturation
SpO2
时间窗: Minute 2
Oxygen saturation
HR
时间窗: Minute 1
Heart rate
HR
时间窗: Minute 2
Heart rate
HR
时间窗: Minute 3
Heart rate
SpO2
时间窗: Minute 3
Oxygen saturation
SpO2
时间窗: Minute 4
Oxygen saturation
SpO2
时间窗: Minute 5
Oxygen saturation
SpO2
时间窗: Minute 6
Oxygen saturation
EtCO2
时间窗: Minute 5
End-tidal CO2
EtCO2
时间窗: Minute 6
End-tidal CO2
RR
时间窗: Minute 1
Respiratory rate
RR
时间窗: Minute 2
Respiratory rate
RR
时间窗: Minute 3
Respiratory rate
RR
时间窗: Minute 4
Respiratory rate
RR
时间窗: Minute 5
Respiratory rate
RR
时间窗: Minute 6
Respiratory rate
Temperature
时间窗: Minute 1
Air temperature (in degrees Celsius) within the face mask
Temperature
时间窗: Minute 2
Air temperature (in degrees Celsius) within the face mask
Temperature
时间窗: Minute 3
Air temperature (in degrees Celsius) within the face mask
Temperature
时间窗: Minutε 4
Air temperature (in degrees Celsius) within the face mask
Temperature
时间窗: Minute 5
Air temperature (in degrees Celsius) within the face mask
Temperature
时间窗: Minute 6
Air temperature (in degrees Celsius) within the face mask
Humidity
时间窗: Minute 1
Relative air humidity (%) within the face mask
Humidity
时间窗: Minute 2
Relative air humidity (%) within the face mask
Humidity
时间窗: Minute 3
Relative air humidity (%) within the face mask
Humidity
时间窗: Minute 4
Relative air humidity (%) within the face mask
Humidity
时间窗: Minute 5
Relative air humidity (%) within the face mask
Humidity
时间窗: Minute 6
Relative air humidity (%) within the face mask
次要结局
未报告次要终点
研究者
Fouzas Sotirios
Assistant Professor of Pediatrics
University of Patras