Cardiorespiratory and Acid-basic Imbalance Caused by Use of Mask

February 25, 2022 updated by: José Dias da Silva Neto, Universidade do Vale do Sapucai

Cardiorespiratory and Acid-basic Imbalance Caused by Use of Face Mask, During Physical Exercices

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • MG
      • Pouso Alegre, MG, Brazil, 13140-564
        • Univás
    • Minas Gerais
      • Pouso Alegre, Minas Gerais, Brazil, 37550000
        • Univás

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
variation of lactate
Time Frame: 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
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
variation of pH
Time Frame: 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
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
variation of P02
Time Frame: 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
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
variation of PC02
Time Frame: 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
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
variation of Sat02
Time Frame: 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
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
variation of bicarbonate
Time Frame: 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
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
heart rate (bpm)
Time Frame: 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
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
blood pressure
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Vale do Sapucai

Investigators

  • Principal Investigator: Antonio Brandão, PhD, Universidade do Vale do Sapucai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2020

Primary Completion (Actual)

November 12, 2021

Study Completion (Actual)

January 12, 2022

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 25, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5.026.897

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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