NCT03669848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,116

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

September 12, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2018

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

11 days

First QC Date

September 12, 2018

Last Update Submit

November 8, 2019

Conditions

Carbon Monoxide Poisoning

Keywords

carbon monoxide poisoninge-cigarette usertranscutaneous saturation measurements

Outcome Measures

Primary Outcomes (1)

  • Blood Carbon Monoxide levels measurements

    Measuring blood Carbon Monoxide levels with Pulse CO-oximetry (SpCO)

    Baseline

Study Arms (1)

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

Pulse CO-oximetryOTHER

Measuring blood Carbon Monoxide levels with Pulse CO-oximetry (SpCO)

Pulse CO-oximetry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Active smoker presenting to adult emergency department

You may qualify if:

  • Patient presenting to adult emergency department
  • Age ≥ 18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adult Emergency Department, University Hospital, Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • Leila CAMBONI, MD

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 13, 2018

Study Start

September 12, 2018

Primary Completion

September 23, 2018

Study Completion

September 23, 2018

Last Updated

November 13, 2019

Record last verified: 2019-11

Locations

FR(1)