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

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.

Study Overview

• Status: Terminated
• Conditions: Smoking; Hospitalization
• Intervention / Treatment: Other: Twice-daily expired carbon monoxide (CO) measurements; Other: Minimal control

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Hôpital Arnaud de Villeneuve - CHU de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
% variation in expired CO	Baseline to hospital discharge (expected maximum of 28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stays	Admission and discharge dates are recorded throughout 3 months of follow-up	3 months
Smoking status (never, former current)		Baseline (day 0)
Smoking status (never, former current)		1 month
Smoking status (never, former current)		3 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Jérémy Charriot, MD, University Hospitals of Montpellier, France

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Actual): December 16, 2019
• Study Completion (Actual): June 29, 2020

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 29, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Death; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gasotransmitters; Carbon Monoxide
• Other Study ID Numbers: RECHMPL18_0078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No