Effect of Face Mask on Exhaled Carbon Monoxide of Smokers

NCT ID: NCT04966845

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-02
• Study Completion Date: 2021-07-20

Brief Summary

Study of 120 healthy subjects without cardiovascular disease, 40 smokers of conventional cigarettes, 40 exclusive users of Heat-non-Burn Cigarettes and 40 nonsmokers.

Baseline measurements of CO will be performed in the morning after awakening without the use of any mask when they arrive at hospital. This time point is selected to detect the lowest exhaled CO levels after the abstinence of smoking during the sleep.

After baseline CO measurement, subjects will be randomly assigned to assess exhaled CO concentration at the end of an 8h morning shift wearing a mask at hospital, or to CO assessment at the end of an 8h morning period without mask out of the hospital (usually home stay). Then the subjects will be crossed over to CO assessment at end of an 8h period without mask out of the hospital after their shift or to an 8h afternoon period wearing a mask during an afternoon hospital shift respectively.

Detailed Description

Study of 120 healthy subjects without cardiovascular disease, 40 smokers of conventional cigarettes, 40 exclusive users of Heat-non-Burn Cigarettes and 40 nonsmokers.

All subjects are civil medical personnel working for the National Health System, in a Tertiary University Hospital in Athens. Also, working in a hospital environment will ensure the use of a mask during the shift.

Baseline measurements of CO will be performed in the morning after awakening without the use of any mask when they arrived at hospital. This time point is selected to detect the lowest exhaled CO levels after the abstinence of smoking during the sleep. CO has a half-life of 5-6 hours and consequently CO levels after the period of sleep (almost 8 hours) verge to decline or to normalize.

After baseline CO measurement, subjects will be randomly assigned to assess exhaled CO concentration at the end of an 8h morning shift wearing a mask at hospital, or to CO assessment at the end of an 8h morning period without mask out of the hospital (usually home stay). Then the subjects will be crossed over to CO assessment at end of an 8h period without mask out of the hospital after their shift or to an 8h afternoon period wearing a mask during an afternoon hospital shift respectively.

Measurements with and without mask will be done one hour after smoking the last cigarette. Subjects are inducted to smoke the same number of cigarettes or heats during their shift while wearing the mask as well as during the out-hospital period when not using a mask. During their shift they are instructed to wear the surgical mask constantly.

Conditions

Concentration of Exhaled Carbon Monoxide

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Smokers

Exclusive smokers of conventional cigarettes

measurement of concentration on exhaled Carbon Monoxide

Intervention Type: DIAGNOSTIC_TEST

exhaled carbon monoxide (eCO) concentration \[parts per million (ppm) was measured by a specific device \[Bedfont Scientific, Maidstone, Kent UK\]

HNBC

Exclusive smokers of Heat-Not-Burn Cigarettes (HNBC)

measurement of concentration on exhaled Carbon Monoxide

Intervention Type: DIAGNOSTIC_TEST

exhaled carbon monoxide (eCO) concentration \[parts per million (ppm) was measured by a specific device \[Bedfont Scientific, Maidstone, Kent UK\]

Nonsmokers

Subjects that abstain from smoking for at least one year

measurement of concentration on exhaled Carbon Monoxide

Intervention Type: DIAGNOSTIC_TEST

exhaled carbon monoxide (eCO) concentration \[parts per million (ppm) was measured by a specific device \[Bedfont Scientific, Maidstone, Kent UK\]

Interventions

measurement of concentration on exhaled Carbon Monoxide

exhaled carbon monoxide (eCO) concentration \[parts per million (ppm) was measured by a specific device \[Bedfont Scientific, Maidstone, Kent UK\]

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Healthy individuals without cardiovascular disease. 40 smokers of conventional cigarettes , 40 exclusive users of Heat-non-Burn Cigarettes and 40 nonsmokers.

Exclusion Criteria

• i) abnormal renal function, ii) hepatic failure (bilirubin> 2 mg / dl), iii) active malignancy, iv) patients treated with drugs that affect platelet function, v) history of coronary artery disease or peripheral artery disease, vi) history of cardiomyopathy, vii) age<21 years old, viii) patients with thrombocytopenia (PLTs < 100x109/L), ix) anemia (HCT <28%), x) alcohol or drug abuse, xi) pregnancy, xii) risk factors for cardiovascular disease.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Ignatios Ikonomidis

Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ignatios Ikonomidis, Professor

Role: PRINCIPAL_INVESTIGATOR

National and Kapodistrian University of Athens

Locations

Konstantinos Katogiannis

Athens, Attica, Greece

"Attikon" University General Hospital

Athens, Attica, Greece

Countries

Greece

References

Ikonomidis I, Katogiannis K, Kourea K, Gavriella K, Tsilivarakis D, Lambadiari V, Kouretas D, Biondi-Zoccai G. The effect of smoking on exhaled carbon monoxide and arterial elasticity during prolonged surgical mask use in the COVID-19 era. Eur J Prev Cardiol. 2022 Nov 15;29(16):e355-e358. doi: 10.1093/eurjpc/zwac101. No abstract available.

Reference Type: DERIVED

PMID: 35798027 (View on PubMed)

Other Identifiers

ExhaledCO

Identifier Type: -

Identifier Source: org_study_id