Cardiorespiratory and Acid-basic Imbalance Caused by Use of Mask

Universidade do Vale do Sapucai

Status: Completed

Conditions: Acid-Base Imbalance; Respiration Disorders

Treatments: Device: Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane

Study type: Interventional

Funder types: Other

Identifiers

NCT05270538

5.026.897

Details and patient eligibility

About

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.

Full description

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.

As an additional safety measure, especially for participants who have to perform the exercise without mask, since they can reinfect themselves, mobile transparent polymer plates for both groups will be temporarily installed around the treadmill. The appliance will be sanitized after each participant used it, with alcohol 70.

After performing the exercise, participants must complete the socio-demographic form sent via Forms in order to characterize such group regarding gender, weight age of participants.

The data acquired through the experiment received static treatments such as a. Classificationtest Signed by Wilcoxon by the statistician of the University of Vale do Sapucaí- Univás).

Enrollment: 57 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy medical students who practice physical activity regularly, at least 3 times a week.

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

comparison of clinical and gasometric parameters between the study group and the control group

Active Comparator group

Description:

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.

Treatment:

Device: Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane