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Completed

NCT Number: NCT04966845

Effect of Face Mask on Exhaled Carbon Monoxide of Smokers

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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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

"Attikon" University General Hospital, Athens, Attica, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

measurement of concentration on exhaled Carbon Monoxide

Diagnostic Test

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

Primary outcomes

  1. Change in exhaled CO levels with the use of surgical face mask

    Time frame: 8 hours

    ppm

  2. Change in exhaled CO levels without the use of surgical face mask

    Time frame: 8 hours

    ppm

Secondary outcomes

  1. Change in Aortic Elastic Properties with the use of surgical face mask

    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)

  2. Change in Aortic Elastic Properties with the use of surgical face mask

    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)

  3. Change in Aortic Elastic Properties with the use of surgical face mask

    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)

  4. Change in Aortic Elastic Properties without the use of surgical face mask

    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).

  5. Change in Aortic Elastic Properties without the use of surgical face mask

    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).

  6. Change in Aortic Elastic Properties without the use of surgical face mask

    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).

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2021
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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