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Cardiorespiratory and Acid-basic Imbalance Caused by Use of Mask

Primary Purpose

Acid-Base Imbalance, Respiration Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane
Sponsored by
Universidade do Vale do Sapucai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acid-Base Imbalance focused on measuring Masks, Acid-Base Imbalance, physiology

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Univas
  • Univás

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

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

Arm 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.

Outcomes

Primary Outcome Measures

variation of lactate
arterial puncture for blood gas analysis
variation of pH
arterial puncture for blood gas analysis
variation of P02
arterial puncture for blood gas analysis
variation of PC02
arterial puncture for blood gas analysis
variation of Sat02
arterial puncture for blood gas analysis
variation of bicarbonate
arterial puncture for blood gas analysis
heart rate (bpm)
physical examination of the cardiovascular system
blood pressure
physical examination of the cardiovascular system

Secondary Outcome Measures

Full Information

First Posted
February 15, 2022
Last Updated
February 25, 2022
Sponsor
Universidade do Vale do Sapucai
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1. Study Identification

Unique Protocol Identification Number
NCT05270538
Brief Title
Cardiorespiratory and Acid-basic Imbalance Caused by Use of Mask
Official Title
Cardiorespiratory and Acid-basic Imbalance Caused by Use of Face Mask, During Physical Exercices
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 12, 2020 (Actual)
Primary Completion Date
November 12, 2021 (Actual)
Study Completion Date
January 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Vale do Sapucai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acid-Base Imbalance, Respiration Disorders
Keywords
Masks, Acid-Base Imbalance, physiology

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
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.
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
comparison of clinical and gasometric parameters between the study group and the control group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Mask Zero Seam Virus Bac-Off Lupo® 98% Polyamide and 2% Elastane
Intervention Description
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.
Primary Outcome Measure Information:
Title
variation of lactate
Description
arterial puncture for blood gas analysis
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
Title
variation of pH
Description
arterial puncture for blood gas analysis
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
Title
variation of P02
Description
arterial puncture for blood gas analysis
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
Title
variation of PC02
Description
arterial puncture for blood gas analysis
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
Title
variation of Sat02
Description
arterial puncture for blood gas analysis
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
Title
variation of bicarbonate
Description
arterial puncture for blood gas analysis
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
Title
heart rate (bpm)
Description
physical examination of the cardiovascular system
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
Title
blood pressure
Description
physical examination of the cardiovascular system
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Brandão, PhD
Organizational Affiliation
Universidade do Vale do Sapucai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univas
City
Pouso Alegre
State/Province
MG
ZIP/Postal Code
13140-564
Country
Brazil
Facility Name
Univás
City
Pouso Alegre
State/Province
Minas Gerais
ZIP/Postal Code
37550000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11116118
Citation
Brum PC, Da Silva GJ, Moreira ED, Ida F, Negrao CE, Krieger EM. Exercise training increases baroreceptor gain sensitivity in normal and hypertensive rats. Hypertension. 2000 Dec;36(6):1018-22. doi: 10.1161/01.hyp.36.6.1018.
Results Reference
background
PubMed Identifier
7498982
Citation
Gava NS, Veras-Silva AS, Negrao CE, Krieger EM. Low-intensity exercise training attenuates cardiac beta-adrenergic tone during exercise in spontaneously hypertensive rats. Hypertension. 1995 Dec;26(6 Pt 2):1129-33. doi: 10.1161/01.hyp.26.6.1129.
Results Reference
background
PubMed Identifier
1342828
Citation
Negrao CE, Moreira ED, Brum PC, Denadai ML, Krieger EM. Vagal and sympathetic control of heart rate during exercise by sedentary and exercise-trained rats. Braz J Med Biol Res. 1992;25(10):1045-52.
Results Reference
background
PubMed Identifier
15558199
Citation
Medeiros A, Oliveira EM, Gianolla R, Casarini DE, Negrao CE, Brum PC. Swimming training increases cardiac vagal activity and induces cardiac hypertrophy in rats. Braz J Med Biol Res. 2004 Dec;37(12):1909-17. doi: 10.1590/s0100-879x2004001200018. Epub 2004 Nov 17.
Results Reference
background
PubMed Identifier
1434592
Citation
Seccareccia F, Menotti A. Physical activity, physical fitness and mortality in a sample of middle aged men followed-up 25 years. J Sports Med Phys Fitness. 1992 Jun;32(2):206-13.
Results Reference
background
PubMed Identifier
11153048
Citation
Forjaz CL, Tinucci T, Ortega KC, Santaella DF, Mion D Jr, Negrao CE. Factors affecting post-exercise hypotension in normotensive and hypertensive humans. Blood Press Monit. 2000 Oct-Dec;5(5-6):255-62. doi: 10.1097/00126097-200010000-00002.
Results Reference
background
PubMed Identifier
15181391
Citation
Forjaz CL, Cardoso CG Jr, Rezk CC, Santaella DF, Tinucci T. Postexercise hypotension and hemodynamics: the role of exercise intensity. J Sports Med Phys Fitness. 2004 Mar;44(1):54-62.
Results Reference
background
PubMed Identifier
27274679
Citation
Porcari JP, Probst L, Forrester K, Doberstein S, Foster C, Cress ML, Schmidt K. Effect of Wearing the Elevation Training Mask on Aerobic Capacity, Lung Function, and Hematological Variables. J Sports Sci Med. 2016 May 23;15(2):379-86. eCollection 2016 Jun.
Results Reference
background
PubMed Identifier
20861520
Citation
Reis JF, Millet GP, Malatesta D, Roels B, Borrani F, Vleck VE, Alves FB. Are oxygen uptake kinetics modified when using a respiratory snorkel? Int J Sports Physiol Perform. 2010 Sep;5(3):292-300. doi: 10.1123/ijspp.5.3.292.
Results Reference
background
PubMed Identifier
30791079
Citation
Ngomane AY, Fernandes B, Guimaraes GV, Ciolac EG. Hypotensive Effect of Heated Water-based Exercise in Older Individuals with Hypertension. Int J Sports Med. 2019 Apr;40(4):283-291. doi: 10.1055/a-0828-8017. Epub 2019 Feb 21.
Results Reference
background
PubMed Identifier
30204655
Citation
Teodoro CL, Gaspari AF, Berton R, Barbieri JF, Silva M, A A Castano L, Guimaraes P, Moraes AC. Familiarization With Airflow-Restriction Mask During Resistance Exercise: Effect on Tolerance and Total Volume. J Strength Cond Res. 2019 Jul;33(7):1762-1765. doi: 10.1519/JSC.0000000000002828.
Results Reference
background
PubMed Identifier
17893626
Citation
Kellum JA. Disorders of acid-base balance. Crit Care Med. 2007 Nov;35(11):2630-6. doi: 10.1097/01.CCM.0000286399.21008.64.
Results Reference
background
PubMed Identifier
28039289
Citation
MacIntyre CR, Zhang Y, Chughtai AA, Seale H, Zhang D, Chu Y, Zhang H, Rahman B, Wang Q. Cluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness. BMJ Open. 2016 Dec 30;6(12):e012330. doi: 10.1136/bmjopen-2016-012330.
Results Reference
background
PubMed Identifier
32355904
Citation
Eikenberry SE, Mancuso M, Iboi E, Phan T, Eikenberry K, Kuang Y, Kostelich E, Gumel AB. To mask or not to mask: Modeling the potential for face mask use by the general public to curtail the COVID-19 pandemic. Infect Dis Model. 2020 Apr 21;5:293-308. doi: 10.1016/j.idm.2020.04.001. eCollection 2020.
Results Reference
background

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Cardiorespiratory and Acid-basic Imbalance Caused by Use of Mask

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