Clinical trial NCT04966845: Effect of Face Mask on Exhaled Carbon Monoxide of Smokers
Official title: The Effect of Surgical Face Mask on Exhaled Carbon Monoxide for Smokers During the COVID-19 Era.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concentration of Exhaled Carbon Monoxide
Keywords: smoking; heat-not-burn cigarette; face mask; Carbon Monoxide
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 120 healthy subjects without cardiovascular disease, 40 smokers of conventional cigarettes , 40 exclusive users of Heat-non-Burn Cigarettes and 40 nonsmokers. All subjects were civil medical personnel working for the National Health System, in a Tertiary University Hospital in Athens. They were all vaccinated and frequently tested for COVID-19. Also, working in a hospital environment ensured the use of a mask during the shift.

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.

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.

Primary outcomes:
measure: Change in exhaled CO levels with the use of surgical face mask
timeFrame: 8 hours
measure: Change in exhaled CO levels without the use of surgical face mask
timeFrame: 8 hours
Secondary outcomes:
measure: Change in Aortic Elastic Properties with the use of surgical face mask
timeFrame: 8 hours
measure: Change in Aortic Elastic Properties with the use of surgical face mask
timeFrame: 8 hours
measure: Change in Aortic Elastic Properties with the use of surgical face mask
timeFrame: 8 hours
measure: Change in Aortic Elastic Properties without the use of surgical face mask
timeFrame: 8 hours
measure: Change in Aortic Elastic Properties without the use of surgical face mask
timeFrame: 8 hours
measure: Change in Aortic Elastic Properties without the use of surgical face mask
timeFrame: 8 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Konstantinos Katogiannis
state: Attiki
city: Athens
country: Greece
facility: "Attikon" University General Hospital
state: Attiki
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Ignatios Ikonomidis, Professor
role: PRINCIPAL_INVESTIGATOR
References: