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

NCT ID: NCT03729063

Last Updated: 2020-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2020-06-29

Brief Summary

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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

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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

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Hospitalization Smoking

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Twice daily expired CO measurements

Patients included in this arm will have expired CO measurements every morning and evening during their initial hospitalization.

Group Type EXPERIMENTAL

Twice-daily expired carbon monoxide (CO) measurements

Intervention Type OTHER

Patients included in this arm will have expired CO measurements every morning and evening during their initial hospitalization.

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.

Group Type ACTIVE_COMPARATOR

Minimal control

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jérémy Charriot, MD

Role: STUDY_DIRECTOR

University Hospitals of Montpellier, France

Locations

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Hôpital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL18_0078

Identifier Type: -

Identifier Source: org_study_id