Impact of Twice-daily Measurement of Expired CO During Ho... | NCT03729063

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

NCT03729063

Sponsor

University Hospital, Montpellier

Status

Terminated

Last Update Posted

Dec 31, 2020Actual

Enrollment

67Actual

Phase

Not Applicable

Conditions

Hospitalization
Smoking

Interventions

Twice-daily expired carbon monoxide (CO) measurements
Minimal control

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in recruiting, many patients with exclusion criteria

Expanded Access Info

Start Date

Nov 19, 2018Actual

Primary Completion Date

Dec 16, 2019Actual

Completion Date

Jun 29, 2020Actual

First Submitted Date

Oct 31, 2018

First Submission Date that Met QC Criteria

Oct 31, 2018

First Posted Date

Nov 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2020

Last Update Posted Date

Dec 31, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jérémy Charriot, MD	University Hospitals of Montpellier, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Arnaud de Villeneuve - CHU de Montpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012907	Smoking

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D014894	Weights and Measures

Ancestor Terms

ID	Term
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

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.