Cardiorespiratory and Acid-basic Imbalance Caused by Use of Face Mask, During Physical Exercices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- variation of lactate
研究概览
简要总结
The study aims to evaluate whether the use of polypropylene and elastane Lupo ® masks can be considered as a significant causal agent in cases of respiratory and acid-base imbalances. For this, gas parameters such as lactate, bicarbonate, Sat02, pH, Sat02, P02 and PC02 of people before and after the practice of aerobic physical exercises will be measured. The control group will perform the exercise without wearing a mask and the study group will perform the exercise using a mask.
详细描述
The experimental phase was carried out at the Armação Atlética academy accredited by the Medical School of Pouso Alegre, following all sanitary recommendations in relation to covid-19.
The aerobic exercise performed by the participants consisted of 15 minutes of running on the treadmill without inclination, interspersing the speeds 10 km/h and 12km/h.
The evaluated clinical parameters of blood pressure, heart rate, pulse , O2 saturation and biochemical analyses of lactate, (partial oxygen pressure) PO2, (partial pressure of CO2 (carbon dioxide) PC02,(hydrogenic potential) pH ,- were collected just before exercise and shortly after that - with maximum interval between measurements of 2 minutes- through physical examination of the cardiovascular apparatus using littmann classic stetoscope iii®,Multilaser® sphygmomanometer and digital oximeter; and arterial blood collection for blood gas analysis.
The blood gas parameters were obtained before and after exercise from blood sample collection by arterial puncture of the Radial Artery performed by the nurses responsible for the blood gas service of the Samuel Libânio Clinic hospital in order to avoid errors regarding the technique. After collection, the samples were kept in a heparinized container and under cooling in an appropriate thermal box and were sent within 20 minutes to the laboratory to be analyzed by blood gas analysis.Such measures avoided the formation of microclots in the samples and the dissipation of blood gases to be analyzed as Co2 and O2 thus bypassing such possible random bias. The blood gas samples obtained were sent to the Hcsl Clinical Analysis laboratory where they underwent gas run in werfen's GEM Premier 3500® apparatus.
To perform the study, we defined a control group and study group based on the use of random sampling software that gave numbers to each participant, distributing them between the two groups. The control group will perform the exercise, without using a mask, while the study group will perform the exercise using Masks Zero Mask Sewing Virus Bac-Off Lupo® for the duration of the exercise.The specific use of this trademark mask made of 98% Polyamide and 2% Elastane ensures that there will be no variations within the study group regarding the composition of the mask, which could result in variable degrees of seals and, therefore, confounding bias to the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Control group (G1) and study group (G2) were defined from the use of random sampling software that gave numbers to each participant, distributing them between the two groups - participants who removed odd numbers were assigned to G1 while participants who removed even numbers to G2.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy medical students who practice physical activity regularly, at least 3 times a week.
排除标准
- •people who do not accept to participate in the study, refusing to sign the free and informed consent form.
- •Sedentary people
- •people with major cardiorespiratory diseases or comorbidity
- •people tested positive for Covid-19 or other respiratory-infectious diseases in less that 15 days
研究组 & 干预措施
comparison of clinical and gasometric parameters between the study group and the control group
To carry out the study, we defined a control group and a study group distributing them between the two groups. The control group will perform the exercise, without using a mask, while the study group will perform the exercise using Masks Zero Mask Sewing Virus Bac-Off Lupo® for the duration of the exercise.
The exercise consisted of 15 minutes of treadmill without inclination interspersing every 2 minutes at speeds 10 Km/h and 12 Km/h, being by definition of a dynamic aerobic exercise of intensity 4 of 5 in the Borg scale- classification of the intensity of physical exercise. Physical activity was performed in water deprivation and fasting at least 30 minutes before the start of activated.
干预措施: Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane (Device)
结局指标
主要结局
variation of lactate
时间窗: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
arterial puncture for blood gas analysis
variation of P02
时间窗: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
arterial puncture for blood gas analysis
variation of pH
时间窗: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
arterial puncture for blood gas analysis
variation of PC02
时间窗: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
arterial puncture for blood gas analysis
variation of Sat02
时间窗: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
arterial puncture for blood gas analysis
variation of bicarbonate
时间窗: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
arterial puncture for blood gas analysis
heart rate (bpm)
时间窗: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
physical examination of the cardiovascular system
blood pressure
时间窗: This variation of blood parameter was obtained through the blood gas analysis to which the participants were submitted just before the beginning of the physical exercise - with a maximum time interval of 2 minutes- and later comparing these
physical examination of the cardiovascular system
次要结局
未报告次要终点
研究者
José Dias da Silva Neto
Phd
Universidade do Vale do Sapucai