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

NCT ID: NCT03124693

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-12
• Study Completion Date: 2008-09-09

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

Study Design

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

Study Groups

Test Group

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

Group Type: EXPERIMENTAL

Rainbow DCI pulse oximeter sensor

Intervention Type: DEVICE

Interventions

Rainbow DCI pulse oximeter sensor

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Age > 18 years old
• Scheduled for surgery requiring frequent schedule blood draws as a part of their routine care

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 Reynauds syndrome
• Hypertension: Systolic BP >= 140 mmHg or Diastolic BP >= 90 mmHg
• Baseline heart rate <50 beats per minute

Surgical Subjects

• Pregnant or lactating women
• Skin abnormalities at the planed application sites that would interfere with transilluminating the finger, or other measurement sites, like burns, scar tissue, nail polish, infections etc.

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

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Masimo Clinical Lab

Irvine, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Mayo Clinic

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

TR-17412-TORP0001

Identifier Type: -

Identifier Source: org_study_id