Impact of Twice-daily Measurement of Expired CO During Hospitalization on Smoking (CoCHU)
Primary Purpose
Hospitalization, Smoking
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Twice-daily expired carbon monoxide (CO) measurements
Minimal control
Sponsored by
About this trial
This is an interventional treatment trial for Hospitalization
Eligibility 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
Sites / Locations
- Hôpital Arnaud de Villeneuve - CHU de Montpellier
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Twice daily expired CO measurements
Control
Arm Description
Patients included in this arm will have expired CO measurements every morning and evening during their initial hospitalization.
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.
Outcomes
Primary Outcome Measures
% variation in expired CO
Secondary Outcome Measures
Length of hospital stays
Admission and discharge dates are recorded throughout 3 months of follow-up
Smoking status (never, former current)
Smoking status (never, former current)
Smoking status (never, former current)
Full Information
NCT ID
NCT03729063
First Posted
October 31, 2018
Last Updated
December 29, 2020
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03729063
Brief Title
Impact of Twice-daily Measurement of Expired CO During Hospitalization on Smoking
Acronym
CoCHU
Official Title
Impact of Twice-daily Measurement of Expired Carbon Monoxide (CO) During Hospitalization in the Pulmonology Ward on Smoking and Smoking Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruiting, many patients with exclusion criteria
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
June 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hospitalization, Smoking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Twice daily expired CO measurements
Arm Type
Experimental
Arm Description
Patients included in this arm will have expired CO measurements every morning and evening during their initial hospitalization.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Twice-daily expired carbon monoxide (CO) measurements
Intervention Description
Patients included in this arm will have expired CO measurements every morning and evening during their initial hospitalization.
Intervention Type
Other
Intervention Name(s)
Minimal control
Intervention Description
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.
Primary Outcome Measure Information:
Title
% variation in expired CO
Time Frame
Baseline to hospital discharge (expected maximum of 28 days)
Secondary Outcome Measure Information:
Title
Length of hospital stays
Description
Admission and discharge dates are recorded throughout 3 months of follow-up
Time Frame
3 months
Title
Smoking status (never, former current)
Time Frame
Baseline (day 0)
Title
Smoking status (never, former current)
Time Frame
1 month
Title
Smoking status (never, former current)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérémy Charriot, MD
Organizational Affiliation
University Hospitals of Montpellier, France
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Arnaud de Villeneuve - CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Twice-daily Measurement of Expired CO During Hospitalization on Smoking
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