HospitalizationCoCHUNCT03729063
Impact of Twice-daily Measurement of Expired CO During Hospitalization on Smoking
A study testing Twice-daily expired carbon monoxide (CO) measurements in people with Hospitalization and Smoking, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The main objective of this study is to show that the repeated (twice-daily) measurement of expired CO during hospitalization helps reduce smoking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalization, Smoking
- What is being tested?
- Twice-daily expired carbon monoxide (CO) measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2018to 29 Jun 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient hospitalized in pneumology for acute respiratory illness or scheduled hospitalization, for a minimum duration of 48h.
- Signature of informed consent
- Patient able to perform all visits and follow the procedures of the study
- Affiliatedor beneficiary of French social security (national health insurance)
Who cannot join
- Subject who can not read and / or write French
- Expected travel that precludes study completion
- Patient in palliative care
- Inability to maintain apnea more than 8 seconds
- Participation in another clinical trial or administration of an off-label drug within 4 weeks prior to inclusion
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier, 34295
About this study
Official title: Impact of Twice-daily Measurement of Expired Carbon Monoxide (CO) During Hospitalization in the Pulmonology Ward on Smoking and Smoking Cessation
The main objective of this study is to show that the repeated (twice-daily) measurement of expired CO during hospitalization helps reduce smoking.
Read the detailed description
Smoking in France represents 25 billion euros per year in care, hospitalizations and drugs and 78000 deaths / year are linked to a pathology attributable to this addiction. In addition, active consumption of cigarettes is a destabilizing factor for chronic respiratory diseases. During hospitalization for acute respiratory illness, evaluation of smoking cessation remains declarative. Although stopping advice and possibly nicotine replacement therapy are prescribed, no objective measure of smoking is performed to assess the adequacy of this attitude.
This project aims to objectively evaluate smoking during hospitalization by measuring twice daily exhaled CO. The impact of this intervention on the duration of hospitalization and smoking 3m after initial admission will also be evaluated. Tobacco consumption patterns based on reason for hospital admission and background pathology will be highlighted.
Secondary objectives include:
- To measure the impact of expired CO measurement during hospitalization on the smoking status 1 month and 3 months after initial admission.
- To determine smoking patterns during hospitalization according to reason for admission and background pathology.
- To measure the effect of iterative CO measurement on the duration of stays.
- To measure and compare the quality of life of patients.
- To study the variability of expired CO measurements.
- Conditions
- Hospitalization, Smoking
- Being tested
- Twice-daily expired carbon monoxide (CO) measurements, Minimal control
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twice-daily expired carbon monoxide (CO) measurementsOther
Patients included in this arm will have expired CO measurements every morning and evening during their initial hospitalization.
Minimal controlOther
Patients included in this arm will have one expired CO measurement on the morning just after initial hospital admission and a second expired CO measurement one the morning prior to discharge.
| Study group | Role | What they receive |
|---|---|---|
| Twice daily expired CO measurements | Experimental | Patients included in this arm will have expired CO measurements every morning and evening during their initial hospitalization. Receives: Other: Twice-daily expired carbon monoxide (CO) measurements |
| Control | Active comparator | Patients included in this arm will have one expired CO measurement on the morning just after initial hospital admission and a second expired CO measurement one the morning prior to discharge. Receives: Other: Minimal control |
What is being measured
The primary outcome is the main question the study is designed to answer.
% variation in expired CO
Measured: Baseline to hospital discharge (expected maximum of 28 days)
Secondary outcomes (4)
Length of hospital stays
Admission and discharge dates are recorded throughout 3 months of follow-up
Measured: 3 months
Smoking status (never, former current)
Measured: Baseline (day 0)
Smoking status (never, former current)
Measured: 1 month
Smoking status (never, former current)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start19 Nov 2018
- Primary completion16 Dec 2019
- Study completion29 Jun 2020
Why it stopped: Difficulty in recruiting, many patients with exclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study is designed to compare one group of patients who had morning (6-8 am) and evening (5-7 pm) measurements of expired carbon monoxide (COexp) every day during their hospitalization (the twice-daily COexp group) versus a second group who had COexp measurements only the first morning following admission and the morning just prior to discharge (control group). A high potential for arm-contamination led the investigators to exclude a randomised design. The frequent COexp intervention was therefore deployed throughout months 1 and 3 of the four-month inclusion period, while the control intervention was deployed on months 2 and 4.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérémy Charriot, MD, Study director, University Hospitals of Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729063
- Sponsor's protocol ID
- RECHMPL18_0078
- Acronym
- CoCHU
- Status last verified
- Dec 2020
- First submitted
- 31 Oct 2018
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Twice-daily Measurement of Expired Carbon Monoxide (CO) During Hospitalization in the Pulmonology Ward on Smoking and Smoking Cessation
- ClinicalTrials.gov ID
- NCT03729063
- Acronym / sponsor ID
- CoCHU / RECHMPL18_0078
- Conditions
- Hospitalization, Smoking
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting, many patients with exclusion criteria
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 2 Nov 2018 (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.
The main objective of this study is to show that the repeated (twice-daily) measurement of expired CO during hospitalization helps reduce smoking.
Detailed description
Smoking in France represents 25 billion euros per year in care, hospitalizations and drugs and 78000 deaths / year are linked to a pathology attributable to this addiction. In addition, active consumption of cigarettes is a destabilizing factor for chronic respiratory diseases. During hospitalization for acute respiratory illness, evaluation of smoking cessation remains declarative. Although stopping advice and possibly nicotine replacement therapy are prescribed, no objective measure of smoking is performed to assess the adequacy of this attitude.
This project aims to objectively evaluate smoking during hospitalization by measuring twice daily exhaled CO. The impact of this intervention on the duration of hospitalization and smoking 3m after initial admission will also be evaluated. Tobacco consumption patterns based on reason for hospital admission and background pathology will be highlighted.
Secondary objectives include:
- To measure the impact of expired CO measurement during hospitalization on the smoking status 1 month and 3 months after initial admission.
- To determine smoking patterns during hospitalization according to reason for admission and background pathology.
- To measure the effect of iterative CO measurement on the duration of stays.
- To measure and compare the quality of life of patients.
- To study the variability of expired CO measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is designed to compare one group of patients who had morning (6-8 am) and evening (5-7 pm) measurements of expired carbon monoxide (COexp) every day during their hospitalization (the twice-daily COexp group) versus a second group who had COexp measurements only the first morning following admission and the morning just prior to discharge (control group). A high potential for arm-contamination led the investigators to exclude a randomised design. The frequent COexp intervention was therefore deployed throughout months 1 and 3 of the four-month inclusion period, while the control intervention was deployed on months 2 and 4.
| Arm | Type | Receives |
|---|---|---|
| Twice daily expired CO measurements | Experimental | Other: Twice-daily expired carbon monoxide (CO) measurementsPatients included in this arm will have expired CO measurements every morning and evening during their initial hospitalization. |
| Control | Active comparator | Other: Minimal controlPatients included in this arm will have one expired CO measurement on the morning just after initial hospital admission and a second expired CO measurement one the morning prior to discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient hospitalized in pneumology for acute respiratory illness or scheduled hospitalization, for a minimum duration of 48h.
- Signature of informed consent
- Patient able to perform all visits and follow the procedures of the study
- Affiliatedor beneficiary of French social security (national health insurance)
Key exclusion criteria (5 listed)
- Subject who can not read and / or write French
- Expected travel that precludes study completion
- Patient in palliative care
- Inability to maintain apnea more than 8 seconds
- Participation in another clinical trial or administration of an off-label drug within 4 weeks prior to inclusion
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 |
|---|---|---|
| Twice-daily expired carbon monoxide (CO) measurementsPatients included in this arm will have expired CO measurements every morning and evening during their initial hospitalization. | Other | Twice daily expired CO measurements |
| Minimal controlPatients included in this arm will have one expired CO measurement on the morning just after initial hospital admission and a second expired CO measurement one the morning prior to discharge. | Other | Control |
Primary outcome
% variation in expired CO
Time frame: Baseline to hospital discharge (expected maximum of 28 days)
4 secondary outcomes
Length of hospital stays
Time frame: 3 months
Smoking status (never, former current)
Time frame: Baseline (day 0)
Smoking status (never, former current)
Time frame: 1 month
Smoking status (never, former current)
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Difficulty in recruiting, many patients with exclusion criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Jérémy Charriot, MD study director
University Hospitals of Montpellier, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twice-daily expired carbon monoxide (CO) measurements in people with Hospitalization and Smoking, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 was stopped early (reason given: Difficulty in recruiting, many patients with exclusion criteria). Results are not available in the source record.
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?
% variation in expired CO (time frame: Baseline to hospital discharge (expected maximum of 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2020.