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

Masimo

Status

Completed

Conditions

Healthy

Surgery

Treatments

Device: DCI pulse oximeter sensor

Study type

Interventional

Funder types

Industry

Identifiers

NCT03124901

TR-17636-56044

Details and patient eligibility

About

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.

Enrollment

147 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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