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Impact of Twice-daily Measurement of Expired CO During Hospitalization on Smoking (CoCHU)

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ClinicalTrials.gov Identifier: NCT03729063
Recruitment Status : Terminated (Difficulty in recruiting, many patients with exclusion criteria)
First Posted : November 2, 2018
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
The main objective of this study is to show that the repeated (twice-daily) measurement of expired CO during hospitalization helps reduce smoking.

Condition or disease Intervention/treatment Phase
Hospitalization Smoking Other: Twice-daily expired carbon monoxide (CO) measurements Other: Minimal control Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Impact of Twice-daily Measurement of Expired Carbon Monoxide (CO) During Hospitalization in the Pulmonology Ward on Smoking and Smoking Cessation
Actual Study Start Date : November 19, 2018
Actual Primary Completion Date : December 16, 2019
Actual Study Completion Date : June 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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Arm Intervention/treatment
Experimental: Twice daily expired CO measurements
Patients included in this arm will have expired CO measurements every morning and evening during their initial hospitalization.
 Other: Twice-daily expired carbon monoxide (CO) measurements
Patients included in this arm will have expired CO measurements every morning and evening during their initial hospitalization.
Active Comparator: Control
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.
 Other: Minimal control
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.


Outcome Measures
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Primary Outcome Measures :
  1. % variation in expired CO [ Time Frame: Baseline to hospital discharge (expected maximum of 28 days) ]

Secondary Outcome Measures :
  1. Length of hospital stays [ Time Frame: 3 months ]
    Admission and discharge dates are recorded throughout 3 months of follow-up

  2. Smoking status (never, former current) [ Time Frame: Baseline (day 0) ]
  3. Smoking status (never, former current) [ Time Frame: 1 month ]
  4. Smoking status (never, former current) [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Contacts and Locations
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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): NCT03729063


Locations
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France
Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Jérémy Charriot, MD University Hospitals of Montpellier, France
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03729063    
Other Study ID Numbers: RECHMPL18_0078
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Death
Pathologic Processes
Carbon Monoxide
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs