Skip to main content
OpenTrials
Completed

NCT Number: NCT03124693

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo Clinical Lab, Irvine, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Surgical Subjects

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Rainbow DCI pulse oximeter sensor

Device

Primary outcomes

  1. Accuracy of Sensor by Arms Calculation

    Time frame: Up to 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 24, 2017
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.