Concentration of Exhaled Carbon MonoxideNCT04966845
Effect of Face Mask on Exhaled Carbon Monoxide of Smokers
An observational study of Concentration of Exhaled Carbon Monoxide, run by University of Athens at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Concentration of Exhaled Carbon Monoxide
- What is being tested?
- measurement of concentration on exhaled Carbon Monoxide
- How many people
- 120 participants
- Where
- 2 sitesGreece
- Study dates
- 2 Jul 2021to 20 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy individuals without cardiovascular disease. 40 smokers of conventional cigarettes , 40 exclusive users of Heat-non-Burn Cigarettes and 40 nonsmokers.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Konstantinos Katogiannis
Athens, Attica, 12461
"Attikon" University General Hospital
Athens, Attica, 12462
About this study
Official title: The Effect of Surgical Face Mask on Exhaled Carbon Monoxide for Smokers During the COVID-19 Era.
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.
Read the 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.
- Conditions
- Concentration of Exhaled Carbon Monoxide
- Being tested
- measurement of concentration on exhaled Carbon Monoxide
- Keywords
- smoking; heat-not-burn cigarette; face mask; Carbon Monoxide
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of concentration on exhaled Carbon MonoxideDiagnostic test
exhaled carbon monoxide (eCO) concentration [parts per million (ppm) was measured by a specific device [Bedfont Scientific, Maidstone, Kent UK]
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Exclusive smokers of conventional cigarettes Receives: Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide | |
| HNBC | Exclusive smokers of Heat-Not-Burn Cigarettes (HNBC) Receives: Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide | |
| Nonsmokers | Subjects that abstain from smoking for at least one year Receives: Diagnostic Test: measurement of concentration on exhaled Carbon Monoxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exhaled CO levels with the use of surgical face mask
ppm
Measured: 8 hours
Change in exhaled CO levels without the use of surgical face mask
ppm
Measured: 8 hours
Secondary outcomes (6)
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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start2 Jul 2021
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Concentration of Exhaled Carbon MonoxideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignatios Ikonomidis, University of Athens
- Investigators
- Ignatios Ikonomidis, Professor, Principal investigator, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966845
- Sponsor's protocol ID
- ExhaledCO
- Status last verified
- May 2024
- First submitted
- 8 Jul 2021
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ikonomidis I, Katogiannis K, Kourea K, Gavriella K, Tsilivarakis D, Lambadiari V, Kouretas D, Biondi-Zoccai G. The effect of smoking on exhaled carbon monoxide and arterial elasticity during prolonged surgical mask use in the COVID-19 era. Eur J Prev Cardiol. 2022 Nov 15;29(16):e355-e358. doi: 10.1093/eurjpc/zwac101. No abstract available.
PubMed 35798027
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Surgical Face Mask on Exhaled Carbon Monoxide for Smokers During the COVID-19 Era.
- ClinicalTrials.gov ID
- NCT04966845
- Acronym / sponsor ID
- ExhaledCO
- Conditions
- Concentration of Exhaled Carbon Monoxide
- Keywords
- smoking; heat-not-burn cigarette; face mask; Carbon Monoxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | Diagnostic Test: measurement of concentration on exhaled Carbon MonoxideExclusive smokers of conventional cigarettes |
| HNBC | – | Diagnostic Test: measurement of concentration on exhaled Carbon MonoxideExclusive smokers of Heat-Not-Burn Cigarettes (HNBC) |
| Nonsmokers | – | Diagnostic Test: measurement of concentration on exhaled Carbon MonoxideSubjects that abstain from smoking for at least one year |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Healthy individuals without cardiovascular disease. 40 smokers of conventional cigarettes , 40 exclusive users of Heat-non-Burn Cigarettes and 40 nonsmokers.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of concentration on exhaled Carbon Monoxideexhaled carbon monoxide (eCO) concentration [parts per million (ppm) was measured by a specific device [Bedfont Scientific, Maidstone, Kent UK] | Diagnostic test | HNBC, Nonsmokers, Smokers |
Primary outcome
Change in exhaled CO levels with the use of surgical face mask
Time frame: 8 hours
ppm
Change in exhaled CO levels without the use of surgical face mask
Time frame: 8 hours
ppm
6 secondary outcomes
Change in Aortic Elastic Properties with the use of surgical face mask
Time frame: 8 hours
Change in Aortic Elastic Properties with the use of surgical face mask
Time frame: 8 hours
Change in Aortic Elastic Properties with the use of surgical face mask
Time frame: 8 hours
Change in Aortic Elastic Properties without the use of surgical face mask
Time frame: 8 hours
Change in Aortic Elastic Properties without the use of surgical face mask
Time frame: 8 hours
Change in Aortic Elastic Properties without the use of surgical face mask
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Derived from this study: PubMed 35798027Ikonomidis I, Katogiannis K, Kourea K, Gavriella K, Tsilivarakis D, Lambadiari V, Kouretas D, Biondi-Zoccai G. The effect of smoking on exhaled carbon monoxide and arterial elasticity during prolonged surgical mask use in the COVID-19 era. Eur J Prev Cardiol. 2022 Nov 15;29(16):e355-e358. doi: 10.1093/eurjpc/zwac101. No abstract available.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignatios Ikonomidis, Professor principal investigator
National and Kapodistrian University of Athens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concentration of Exhaled Carbon Monoxide, run by University of Athens at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in exhaled CO levels with the use of surgical face mask (time frame: 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04966845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.