Is Transcutaneous Carbon Monoxide Saturation of E-cigaret... | NCT03669848

Studies
Is Transcutaneous Carbon Monoxide Saturation of E-cigarette Users Comparable to That of Smokers?

NCT03669848

Sponsor

University Hospital, Tours

Status

Completed

Last Update Posted

Nov 13, 2019Actual

Enrollment

1,116Actual

Phase

Not provided

Conditions

Carbon Monoxide Poisoning

Interventions

Pulse CO-oximetry

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

ID	Type	Description	Link
2018-A01471-54	Other Identifier	IdRCB

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 12, 2018Actual

Primary Completion Date

Sep 23, 2018Actual

Completion Date

Sep 23, 2018Actual

First Submitted Date

Sep 12, 2018

First Submission Date that Met QC Criteria

Sep 12, 2018

First Posted Date

Sep 13, 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

Nov 8, 2019

Last Update Posted Date

Nov 13, 2019Actual

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

Suspicions of carbon monoxide poisoning that lead to the treatment of victims are numerous. Measurement of transcutaneous carbon monoxide saturation (SpCO) is a useful diagnostic and triage tool for victims and the toxic threshold is clearly defined for both non-smokers (SpCO> 5%) and smokers ( SpCO> 10%).

Currently, the use of e-cigarettes is democratizing. Unfortunately, the threshold for toxic SpCO is not defined for this patient profile.

The risk is treating in excess or worse than underestimating carbon monoxide poisoning in e-cigarette users who would be exposed to carbon monoxide exposure.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,116Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulse CO-oximetry		Measuring blood Carbon Monoxide levels with Pulse CO-oximetry (SpCO) Measurements are taken with a noninvasive method by placing a sensor on a patient, usually on the fingertip.	Other: Pulse CO-oximetry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulse CO-oximetry	Other	Measuring blood Carbon Monoxide levels with Pulse CO-oximetry (SpCO)	Pulse CO-oximetry

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Carbon Monoxide levels measurements	Measuring blood Carbon Monoxide levels with Pulse CO-oximetry (SpCO)	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient presenting to adult emergency department
Age ≥ 18 years

Exclusion Criteria:

Passive exposure to tobacco
Mixed exposure (tobacco / e-cigarette)
Patient having objected to the processing of his data

Accepts Healthy Volunteers

Yes

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

Active smoker presenting to adult emergency department

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leila CAMBONI, MD	University Hospital, Tours	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Adult Emergency Department, University Hospital, Tours		Tours		37044	France

Condition Browse Module

MeSH Terms

ID	Term
D002249	Carbon Monoxide Poisoning

Ancestor Terms

ID	Term
D005739	Gas Poisoning
D011041	Poisoning
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided