NCT00788983

Brief Summary

Validate Non-Motion SpO2 Accuracy from 70%-100% of various pulse oximeter/ sensor combinations and various OEM pulse oximeter modules and sensor combinations during induced hypoxia (desaturation).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2008

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

November 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
Last Updated

September 20, 2013

Status Verified

December 1, 2008

Enrollment Period

Same day

First QC Date

November 7, 2008

Last Update Submit

September 19, 2013

Conditions

Hypoxia

Keywords

Induced hypoxiaPulse oximeterNonin MedicalVerification of SpO2 accuracy

Outcome Measures

Primary Outcomes (1)

  • SpO2 Accuracy Verification Study (Arms)of ≤3 between 70 & 100%

    During Analysis

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy, consenting, non-smoking subjects, 18 years or greater, both genders and a range of skin tones

You may qualify if:

  • Non-smokers
  • Healthy; no known blood disorders
  • Finger sizes within the sensor specifications
  • Minimum 18 years of age

You may not qualify if:

  • Artificial nails or fingernail polish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco, Induced Hypoxia Lab

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Philip E Bickler, MD

    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

November 7, 2008

First Posted

November 11, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

September 20, 2013

Record last verified: 2008-12

Locations

US(1)