Accuracy of Pulse Oximeters With Profound Hypoxia

NCT02571686 | Completed

• 1 other identifier: 139253
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a laboratory hemoximeter). The data obtained is submitted by pulse oximeter manufacturers to the FDA for device approval.

Conditions

Oximetry, Pulse

Outcome Measures

Primary Outcomes (1)

• Accuracy of Pulse Oximeter

  2 months

Interventions

Surveyor S4 DEVICE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

10-12 healthy volunteers

You may qualify if:

• The subject is male or female, aged ≥18 and \<50.
• The subject is in good general health with no evidence of any medical problems.
• The subject is fluent in both written and spoken English.
• The subject has provided informed consent and is willing to comply with the study procedures.

You may not qualify if:

• The subject is obese (BMI\>30).
• The subject has a known history of heart disease, lung disease, kidney or liver disease.
• Diagnosis of asthma, sleep apnea, or use of CPAP(Continuous positive airway pressure).
• Subject has diabetes.
• Subject has a clotting disorder.
• The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
• The subject has any other serious systemic illness.
• The subject is a current smoker.
• Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
• The subject has a history of fainting or vasovagal response.
• The subject has a history of sensitivity to local anesthesia.
• The subject has a diagnosis of Raynaud's disease.
• The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
• The subject is pregnant, lactating or trying to get pregnant.
• The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.

Sponsors & Collaborators

• Mortara Instrument: lead

Study Sites (1)

Department of Anesthesia Clinical Studies Facility, room A-65 Parnassus Campus.

San Francisco, California, 94143, United States

Location

Study Design

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

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 8, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

US (1)