measurement of concentration on exhaled Carbon Monoxide
Diagnostic Testexhaled carbon monoxide (eCO) concentration [parts per million (ppm) was measured by a specific device [Bedfont Scientific, Maidstone, Kent UK]
NCT Number: NCT04966845
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.
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Notify Me21 year–70 year
All sexes
Observational
"Attikon" University General Hospital, Athens, Attica, Greece
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
exhaled carbon monoxide (eCO) concentration [parts per million (ppm) was measured by a specific device [Bedfont Scientific, Maidstone, Kent UK]
Time frame: 8 hours
ppm
Time frame: 8 hours
ppm
Time frame: 8 hours
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
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
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
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
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
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).
University of Athens
Other
The Effect of Surgical Face Mask on Exhaled Carbon Monoxide for Smokers During the COVID-19 Era.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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