NCT02950701

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

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

October 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2017

Completed
Last Updated

June 26, 2018

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

October 28, 2016

Last Update Submit

June 25, 2018

Conditions

Carbon Monoxide Intoxication

Outcome Measures

Primary Outcomes (1)

  • Values from the test device will be compared to the values from the reference device.

    Through study completion, an average of 1 year.

Interventions

Observational data collection.DEVICE

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 during medical transport.

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)

HealthEast Medical Transportation

Saint Paul, Minnesota, 55106, United States

Location

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • Keith Wesley, MD

    HealthEast Medical Transport

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 1, 2016

Study Start

November 1, 2016

Primary Completion

September 22, 2017

Study Completion

September 22, 2017

Last Updated

June 26, 2018

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)