Effect of Face Mask on Exhaled Carbon Monoxide of Smokers

Study Overview
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Brief Summary
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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
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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 heets 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.

Official Title
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The Effect of Surgical Face Mask on Exhaled Carbon Monoxide for Smokers During the COVID-19 Era.

Conditions
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Concentration of Exhaled Carbon Monoxide

Intervention / Treatment
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* Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Smokers<br>Exclusive smokers of convnetional cigarettes | Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide<br>* Εxhaled carbon monoxide (eCO) concentration [parts per million (ppm) was measured by a specific device [Bedfont Scientific, Maidstone, Kent UK]<br>|
| HNBC<br>Exclusive smokers of Heat-Not-Burn Cigarettes (HNBC) | Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide<br>* Εxhaled carbon monoxide (eCO) concentration [parts per million (ppm) was measured by a specific device [Bedfont Scientific, Maidstone, Kent UK]<br>|
| Nonsmokers<br>Subjects that abstain from smoking for at least one year | Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide<br>* Εxhaled carbon monoxide (eCO) concentration [parts per million (ppm) was measured by a specific device [Bedfont Scientific, Maidstone, Kent UK]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exhaled CO levels with the use of surgical face mask |  | 8 hours | 
| Change in exhaled CO levels without the use of surgical face mask |  | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking; heat-not-burn cigarette; face mask; Carbon Monoxide