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

NCT03729063 | Terminated

• 1 other identifier: RECHMPL18_0078
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospitalization; Smoking

Outcome Measures

Primary Outcomes (1)

• % variation in expired CO

  Baseline to hospital discharge (expected maximum of 28 days)

Secondary Outcomes (4)

• Length of hospital stays

  3 months

• Smoking status (never, former current)

  Baseline (day 0)

• Smoking status (never, former current)

  1 month

• Smoking status (never, former current)

  3 months

Study Arms (2)

Twice daily expired CO measurements

EXPERIMENTAL

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

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.

Other: Minimal control

Interventions

Twice-daily expired carbon monoxide (CO) measurements OTHER

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

Twice daily expired CO measurements

Minimal control 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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Hôpital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Smoking

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jérémy Charriot, MD

  University Hospitals of Montpellier, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 2, 2018
• Study Start: November 19, 2018
• Primary Completion: December 16, 2019
• Study Completion: June 29, 2020
• Last Updated: December 31, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)