Cardiorespiratory and Acid-basic Imbalance Caused by Use of Mask
Condition: Acid-Base Imbalance; Respiration Disorders
MeSH terms: Respiration Disorders; Acid-Base Imbalance
Study type: Interventional

Summary: 
      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.
    

Detailed 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).
    

Intervention name(s): Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane
Intervention type(s): Device
Intervention description(s): The 26 participants allocated as G2 had to perform the physical exercise using the Zero Sewing Virus Bac-Off Virus® 98% Polyamide and 2% Elastane, in order to totally seal the nose and mouth.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Of the 57 participants, 26 are allocated as G1 (46.5%) and 31 as G2 (53.5%) After the collection of blood gases and cardiovascular parameters- Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate and O2 Saturation - before and after physical exercise, all participants answered a socio-demographic questionnaire informing their weight, height and gender, in addition to completing the Informed Consent Form on the experiment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Masks; Acid-Base Imbalance; physiology