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Effect of Face Mask on Exhaled Carbon Monoxide of Smokers

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ClinicalTrials.gov Identifier: NCT04966845
Recruitment Status : Recruiting
First Posted : July 19, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

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.


Condition or disease Intervention/treatment
Concentration of Exhaled Carbon Monoxide Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide

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 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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Effect of Surgical Face Mask on Exhaled Carbon Monoxide for Smokers During the COVID-19 Era.
Actual Study Start Date : July 2, 2021
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : July 15, 2021

Group/Cohort Intervention/treatment
Smokers
Exclusive smokers of convnetional cigarettes
Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide
Εxhaled carbon monoxide (eCO) concentration [parts per million (ppm) was measured by a specific device [Bedfont Scientific, Maidstone, Kent UK]

HNBC
Exclusive smokers of Heat-Not-Burn Cigarettes (HNBC)
Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide
Εxhaled carbon monoxide (eCO) concentration [parts per million (ppm) was measured by a specific device [Bedfont Scientific, Maidstone, Kent UK]

Nonsmokers
Subjects that abstain from smoking for at least one year
Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide
Εxhaled carbon monoxide (eCO) concentration [parts per million (ppm) was measured by a specific device [Bedfont Scientific, Maidstone, Kent UK]




Primary Outcome Measures :
  1. Change in exhaled CO levels with the use of surgical face mask [ Time Frame: 8 hours ]
  2. Change in exhaled CO levels without the use of surgical face mask [ Time Frame: 8 hours ]


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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04966845


Contacts
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Contact: Ignatios Ikonomidis, Professor +30 694 480 5732 ignoik@gmail.com
Contact: KONSTANTINOS KATOGIANNIS, Fellow +306938165687 kenndj89@gmail.com

Locations
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Greece
Konstantinos Katogiannis Recruiting
Athens, Attiki, Greece, 12461
Contact: Konstantinos Katogiannis    00302105832187 ext 00302105832187    kenndj89@gmail.com   
"Attikon" University General Hospital Recruiting
Athens, Attiki, Greece, 12462
Principal Investigator: Ignatios Ikonomidis, MD         
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Ignatios Ikonomidis, Professor National and Kapodistrian University of Athens
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Responsible Party: Ignatios Ikonomidis, Professor of Cardiology, University of Athens
ClinicalTrials.gov Identifier: NCT04966845    
Other Study ID Numbers: ExhaledCO
First Posted: July 19, 2021    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ignatios Ikonomidis, University of Athens:
smoking; heat-not-burn cigarette; face mask; Carbon Monoxide
Additional relevant MeSH terms:
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Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs