Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03124901
• Other study ID #: TR17636-56044
• Status: Completed
• Phase: N/A
• First received: April 11, 2017
• Last updated: April 20, 2017
• Start date: September 30, 2008
• Est. completion date: October 27, 2008

Study information

• Verified date: April 2017
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: October 27, 2008
• Est. primary completion date: October 27, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has physical status between ASA 1 or 2

• Able to communicate in English

Exclusion Criteria:

• 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 Reynods syndrome

• Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg

• Baseline heart rate <50 beats per minute

Related Conditions & MeSH terms

• Healthy
• Surgery

Intervention

Device:
• DCI pulse oximeter sensor

Locations

Country	Name	City	State
United States	Masimo Clinical Lab	Irvine	California
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of sensor	Accuracy willl 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