NCT02427685

Brief Summary

The study verifies accuracy of a new pulse co-oximeter in the presence of elevated carboxyhemoglobin levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

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

Study Start

First participant enrolled

April 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 17, 2015

Status Verified

April 1, 2015

Enrollment Period

1 month

First QC Date

April 20, 2015

Last Update Submit

June 16, 2015

Conditions

Elevated Levels of Carboxyhemoglobin

Outcome Measures

Primary Outcomes (1)

  • Carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry.

    3 hours

Secondary Outcomes (1)

  • Oxygen saturation accuracy in conditions of elevated carboxyhemoglobin.

    3 hours

Interventions

Pulse Co-OxDEVICE

Comparison of pulse co-oximeter to blood gas analyzer.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy adult volunteers

You may qualify if:

  • The subject is male or female.
  • The subject is of any racial or ethnic group.
  • The subject is between 18 years and 45 years of age.
  • The subject does not have significant medical problems.
  • The subject is willing to provide written informed consent and is willing and able to comply with study procedures.

You may not qualify if:

  • Has a BMI greater than 31
  • Has had any relevant injury at the sensor location site
  • Has deformities or abnormalities that may prevent proper application of the device under test.
  • Has a known respiratory condition.
  • Is currently a smoker.
  • Has a known heart or cardiovascular condition.
  • Is currently pregnant.
  • Is female and actively trying to get pregnant.
  • Has a clotting disorder.
  • Has Raynaud's Disease.
  • Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia).
  • The subject has a COHb greater than 3% or MetHb greater than 2%.
  • Has taken blood thinners or medication with aspirin within the last 24 hours.
  • Has unacceptable collateral circulation from the ulnar artery.
  • Has donated more than 300 mL of blood within one month prior to start of study.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94118, United States

Location

Study Officials

  • Phillip E Bickler, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 28, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 17, 2015

Record last verified: 2015-04

Locations

US(1)