Accuracy of Methemoglobin Measurement of Various Rainbow Pulse Oximeter Sensors

NCT ID: NCT03124836

Last Updated: 2017-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-18
• Study Completion Date: 2009-12-17

Brief Summary

In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of the noninvasive HbMet measurement by a Pulse Oximeter Sensor will be assessed by comparison to blood measurements from a laboratory analyzer.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

R2-25 Sensor

All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor

Group Type: EXPERIMENTAL

Pulse Oximeter Sensor

Intervention Type: DEVICE

Interventions

Pulse Oximeter Sensor

Intervention Type: DEVICE

Eligibility Criteria

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.

4. Subject has diabetes.

5. Subject has a clotting disorder.

6. The subject has 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 or allergy to the study drugs.

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 has a history of migraine headaches.

16. Th subject is currently taking antidepressants.

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

TR19427-BICK0001

Identifier Type: -

Identifier Source: org_study_id