Cardiorespiratory and Acid-basic Imbalance Caused by Use of Mask

Respiration Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05270538
• Other study ID #: 5.026.897
• Status: Completed
• Phase: N/A
• Start date: November 12, 2020
• Est. completion date: January 12, 2022

Study information

• Verified date: February 2022
• Source: Universidade do Vale do Sapucai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 12, 2022
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Acid-Base Imbalance
• Respiration Disorders

Intervention

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.

Locations

Country	Name	City	State
Brazil	Univas	Pouso Alegre	MG
Brazil	Univás	Pouso Alegre	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

References & Publications (14)

Brum PC, Da Silva GJ, Moreira ED, Ida F, Negrão CE, Krieger EM. Exercise training increases baroreceptor gain sensitivity in normal and hypertensive rats. Hypertension. 2000 Dec;36(6):1018-22. — View 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. — View 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. — View Citation

Forjaz CL, Tinucci T, Ortega KC, Santaella DF, Mion D Jr, Negrão CE. Factors affecting post-exercise hypotension in normotensive and hypertensive humans. Blood Press Monit. 2000 Oct-Dec;5(5-6):255-62. — View Citation

Gava NS, Véras-Silva AS, Negrão 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. — View Citation

Kellum JA. Disorders of acid-base balance. Crit Care Med. 2007 Nov;35(11):2630-6. Review. — View 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. — View Citation

Medeiros A, Oliveira EM, Gianolla R, Casarini DE, Negrão 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. Epub 2004 Nov 17. — View Citation

Negrão 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. — View Citation

Ngomane AY, Fernandes B, Guimarães 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. — View 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. — View 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. — View 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. — View Citation

Teodoro CL, Gáspari AF, Berton R, Barbieri JF, Silva M, A A Castaño L, Guimarães 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variation of lactate	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
Primary	variation of pH	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
Primary	variation of P02	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
Primary	variation of PC02	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
Primary	variation of Sat02	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
Primary	variation of bicarbonate	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
Primary	heart rate (bpm)	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
Primary	blood pressure	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