Accuracy of Noninvasive Hemoglobin Measurement (SpHb) Using Rainbow DCI Pulse Oximeter Sensor

NCT03124693 | Completed Results FDA Device

• 1 other identifier: TR-17412-TORP0001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

In this study, the concentration of hemoglobin within the subject's blood is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration of fluids intravenously for healthy study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparing with blood sample analysis.

Conditions

Healthy; Surgery

Outcome Measures

Primary Outcomes (1)

• Accuracy of Sensor by Arms Calculation

  Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.

  Up to 24 hours

Study Arms (1)

Test Group

EXPERIMENTAL

All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.

Device: Rainbow DCI pulse oximeter sensor

Interventions

Rainbow DCI pulse oximeter sensor DEVICE

Test Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has physical status between ASA 1 or 2
• Able to communicate in English

You may not qualify if:

• Pregnant or sexually active without birth control.
• Hemoglobin less than 11g/dL
• Known alcohol or drug abuse
• Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection
• Nail polish
• Head injury with loss of consciousness within the last year
• Known neurological and psychiatric conditions.
• Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs
• Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Reynauds syndrome
• Hypertension: Systolic BP \>= 140 mmHg or Diastolic BP \>= 90 mmHg
• Baseline heart rate \<50 beats per minute
• Surgical Subjects
• Age \> 18 years old
• Scheduled for surgery requiring frequent schedule blood draws as a part of their routine care
• Pregnant or lactating women

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (3)

Masimo Clinical Lab

Irvine, California, 92618, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Mayo Clinic

Jacksonville, Florida, 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: August 12, 2008
• Primary Completion: September 9, 2008
• Study Completion: September 9, 2008
• Last Updated: June 12, 2017
• Results First Posted: June 12, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)