Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor

NCT03125005 | Completed Results FDA Device

• 1 other identifier: TR22640-BICK0001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

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 a noninvasive HbMet sensor will be assessed by comparison to blood measurements from a laboratory analyzer.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Accuracy of Sensor by Arms Calculation

  Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.

  5 hours

Study Arms (1)

Rainbow Universal Pulse Oximeter Sensor

EXPERIMENTAL

All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.

Device: Rainbow Universal Pulse Oximeter Sensor

Interventions

Rainbow Universal Pulse Oximeter Sensor DEVICE

Rainbow Universal Pulse Oximeter Sensor

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.
• Subject has diabetes.
• Subject has a clotting disorder.
• 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.
• 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 or allergy to the study drugs.
• 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 has a history of migraine headaches.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (2)

Masimo Clinical Lab

Irvine, California, 92618, United States

Location

University of San Francisco

San Francisco, California, 94117, United States

Location

Results Point of Contact

• Title: Vikram Ramakanth
• Organization: Masimo

clinicalresearchdept@masimo.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 24, 2017
• Study Start: April 12, 2012
• Primary Completion: June 21, 2012
• Study Completion: June 21, 2012
• Last Updated: July 27, 2017
• Results First Posted: June 6, 2017

Record last verified: 2017-06

Locations

US (2)