NCT02506010

Brief Summary

The purpose of this study is to conduct an oxygen saturation (SpO2) accuracy validation comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood saturation during non-motion conditions over the range of 60-100% SaO2 as measured by Reference CO-Oximetry. Additionally, the prototype pulse oximeter pulse rate measurements will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 14, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

July 14, 2015

Last Update Submit

October 14, 2016

Conditions

Healthy

Keywords

Hypoxia

Outcome Measures

Primary Outcomes (1)

  • The OxiCable pulse rate measurement performance is an ARMS of 3 or better over the full range 60-100% SaO2.

    2.5 hours

Eligibility Criteria

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

The study population will be ten to fifteen male and female subjects of any race, ranging in pigmentation from light to dark to meet the study design requirements

You may qualify if:

  • healthy
  • non-smoking, or who have refrained from smoking for 2 days
  • male or female of any race
  • years.
  • Subjects must have the ability to understand and provide written informed consent as well as be willing to comply with study procedures.
  • To be eligible to participate in the study, the subject must clear a recent physical (12-lead ECG, medical history and blood test for sickle cell disease.) prior to enrollment

You may not qualify if:

  • \- morbid obesity (defined as BMI \> 39.5),
  • injuries, deformities or abnormalities or piercings that may prevent proper application of the device under test, compromised circulation,
  • subjects with known respiratory conditions (smokers with COHb levels \>3%, flu, pneumonia, bronchitis, shortness of breath/ respiratory distress, severe asthma, emphysema, COPD),
  • subjects with known heart or cardiovascular conditions (uncontrolled hypertension, heart arrhythmias other than sinus arrhythmia, previous heart attack, blocked artery, history of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy, history of stroke, transient ischemic attack or carotid artery disease),
  • other known health condition (diabetes, thyroid disease, kidney disease / chronic renal impairment, history of seizures (except childhood febrile seizures) or epilepsy, or unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer / chemotherapy
  • women actively trying to get pregnant or are pregnant,
  • clotting disorders (history of bleeding disorders or current use of blood thinners, Hemophilia, blood clots)
  • Sickle cell disease
  • Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors
  • Unwillingness or inability to remove colored nail polish or artificial nails from test digit(s)
  • Prior or known allergies to: lidocaine (or similar pharmacological agents, e.g., Novocain) or heparin
  • Recent arterial cannulation (i.e., less than 30 days prior to study date), Six or more arterial cannulations of each (right \& left) radial artery, history of clinically significant complications from previous arterial cannulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinimark

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Ransom, MD

    Clinimark, LLC

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 22, 2015

Study Start

November 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

US(1)