An observational study in Concentration of Exhaled Carbon Monoxide, sponsored by University of Athens. Completed at 2 sites in Greece. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by University of Athens · Observational
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.
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.
325 studies on the registry are indexed under Smoking; 141 are open to participants now.
This study's enrollment of 120 is close to the median of 114 across 69 observational studies indexed under Smoking.
Browse Smoking studies →University of Athens is the lead sponsor of 139 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Exclusive smokers of conventional cigarettes
Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide
Exclusive smokers of Heat-Not-Burn Cigarettes (HNBC)
Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide
Subjects that abstain from smoking for at least one year
Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide
exhaled carbon monoxide (eCO) concentration \[parts per million (ppm) was measured by a specific device \[Bedfont Scientific, Maidstone, Kent UK\]
Change in exhaled CO levels with the use of surgical face mask
ppm
Time frame: 8 hours
Change in exhaled CO levels without the use of surgical face mask
ppm
Time frame: 8 hours
Change in Aortic Elastic Properties with the use of surgical face mask
Aortic elastic properties will be quantified by measuring Pulse Wave Velocity (m/sec), as assessed by a dedicated device(Mobil-O-Graph, IEM GmbH, Aachen, Germany)
Time frame: 8 hours
Change in Aortic Elastic Properties with the use of surgical face mask
Aortic elastic properties will be quantified by measuring augmentation index (%), as assessed by a dedicated device (Mobil-O-Graph, IEM GmbH, Aachen, Germany)
Time frame: 8 hours
Change in Aortic Elastic Properties with the use of surgical face mask
Aortic elastic properties will be quantified by measuring central blood pressure (mm Hg), as assessed by a dedicated device (Mobil-O-Graph, IEM GmbH, Aachen, Germany)
Time frame: 8 hours
Change in Aortic Elastic Properties without the use of surgical face mask
Aortic elastic properties will be quantified by measuring Pulse Wave Velocity (m/sec), as assessed by a dedicated device (Mobil-O-Graph, IEM GmbH, Aachen, Germany).
Time frame: 8 hours
Change in Aortic Elastic Properties without the use of surgical face mask
Aortic elastic properties will be quantified by measuring augmentation index (%), as assessed by a dedicated device (Mobil-O-Graph, IEM GmbH, Aachen, Germany).
Time frame: 8 hours
Change in Aortic Elastic Properties without the use of surgical face mask
Aortic elastic properties will be quantified by measuring central blood pressure (mm Hg), as assessed by a dedicated device (Mobil-O-Graph, IEM GmbH, Aachen, Germany).
Time frame: 8 hours
Plan to share: Undecided
Ran from Jul 2021 to primary completion in Jul 2021, 0 months.
Of 31 observational studies under Smoking, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 17. This study's 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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