Accuracy of Pulse Oximeters With Profound Hypoxia

Oximetry, Pulse Clinical Trial

Official title:

Accuracy of Pulse Oximeters With Profound Hypoxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571686
• Other study ID #: 139253
• Status: Completed
• Phase: N/A
• First received: October 6, 2015
• Last updated: December 22, 2015
• Start date: October 2015
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Mortara Instrument
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Overall design:

Studies normally involve 6-12 normal adult volunteer paid subjects, with 20-25 1-2 ml arterial blood samples from each subject obtained at different steady-state levels of hypoxia from 70-100%. Blood samples obtained from an arterial line are measured in a hemoximeter to determine true saturation value. Some sponsors may not require any blood sampling. Some sponsors may require additional blood samples, up to 35 samples may be drawn.

Readings from the test pulse oximeters are recorded and compared to these "gold-standard" blood values. The pulse oximeter probes may be located at a variety of sites on the subjects, including fingers, toes, ears, forehead, scalp and bridge of the nose. These detector-probes are all non-invasive. The level of hypoxia is measured and controlled by the investigator. A computer program that displays a prediction, breath by breath, the arterial oxygen saturation, (SaO2) of the study subject. SaO2 is computed from end-expired Po2 and Pco2 as determined by mass spectrometer gas analysis. This information permits the inspired gas mixture of air, plus CO2 and nitrogen, to be adjusted by an operator watching the value computed after each expiration on an analog meter. This computer-estimated saturation is adjusted by the operator to one of 6 levels of predicted saturation, and is held stable for about 30 seconds at each level. Two or three "runs" are conducted per subject. Each "run" lasts 8-12 min and 4 to 5 plateaus are tested per run. The manufacturer may choose the target values. Plateaus are typically sought at 92%, 86%, 80%, 74%, 68% and 62%. Other manufacturers have asked for an equal number of data points but with all points between 70% and 100%. Some sponsors may also request additional variables to be measured during testing including high or low Carbon Dioxide (CO2), where subjects will be asked to hyperventilate; low perfusion, where subjects will be asked to lay flat, or with their head up or down; testing pulse oximeters during motion, with the subject's hand fixed to a motion machine; or measure eye-tracking during hypoxia. The subject's will be informed by the study staff and in the consent form if any of these additional procedures apply.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. The subject is male or female, aged =18 and <50.

2. The subject is in good general health with no evidence of any medical problems.

3. The subject is fluent in both written and spoken English.

4. The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

1. The subject is obese (BMI>30).

2. The subject has a known history of heart disease, lung disease, kidney or liver disease.

3. Diagnosis of asthma, sleep apnea, or use of CPAP(Continuous positive airway pressure).

4. Subject has diabetes.

5. Subject has a clotting disorder.

6. 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.

7. The subject has any other serious systemic illness.

8. The subject is a current smoker.

9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.

10. The subject has a history of fainting or vasovagal response.

11. The subject has a history of sensitivity to local anesthesia.

12. The subject has a diagnosis of Raynaud's disease.

13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).

14. The subject is pregnant, lactating or trying to get pregnant.

15. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.

16. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study -

Related Conditions & MeSH terms

• Hypoxia
• Oximetry, Pulse

Intervention

Device:
• Surveyor S4

Locations

Country	Name	City	State
United States	Department of Anesthesia Clinical Studies Facility, room A-65 Parnassus Campus.	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Mortara Instrument

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Pulse Oximeter		2 months