Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia

NCT01253785 | Completed

• 1 other identifier: STER05
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Validate pulse oximeter sensor SpO2 accuracy from 70-100% during induced hypoxia.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• SpO2 Accuracy Verification Study (Arms) of ≤ 3.0% between 70-100%

  During Analysis - data were collected for all subjects on one day

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Non-smoker
• years or older
• Meet the requirements of the investigator's medical history questionnaire criteria which described family history, present symptoms, smoking history, risk factors, nutrition, exercise levels and stress levels
• Understand and provide signed consent for the procedure

You may not qualify if:

• Smoker
• User of illegal drugs
• Hypertension
• Respiratory disease
• Known allergy to Lidocaine or its derivatives
• Those suffering from upper respiratory infection on the day of study

Sponsors & Collaborators

• SterilMed, Inc.: lead

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 3, 2010

Record last verified: 2010-12