NCT03004235

Brief Summary

The purpose of this study is to collect non-invasive observational data in suspected or known carbon monoxide poisoning.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

December 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2019

Completed
Last Updated

August 12, 2019

Status Verified

July 1, 2018

Enrollment Period

2.7 years

First QC Date

December 21, 2016

Last Update Submit

August 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Values from the test device will be compared to the values from co-oximetry to determine the accuracy of the test device

    Through study completion, an average of 2 years.

Interventions

Observational data collection

Eligibility Criteria

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

The participants will be selected based on symptoms in the Emergency Department.

You may qualify if:

  • Known or suspected carbon monoxide poisoning

You may not qualify if:

  • Less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • James Miner, MD

    Hennepin County Medical Center, Minneapolis

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 21, 2016

First Posted

December 28, 2016

Study Start

December 1, 2016

Primary Completion

August 8, 2019

Study Completion

August 8, 2019

Last Updated

August 12, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations