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Non-invasive Continuous Total Hemoglobin Measurement by Pulse CO-Oximetry

NCT04506957 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2020-09-04

No results posted yet for this study

Summary

This study is a data collection/sampling project for transcutaneous continuous Pulse CO-Oximetry and accessories (SW-Version Radical-7® Pulse CO-Oximeter with the Masimo rainbow SETTM, V1.6.2.4i Masimo Corp., Irvine, CA, USA, and the RD rainbow SET-2, Rev-O Fingersensor). The device received the CE Mark in 2012 and is approved by the Swiss Medic for clinical use. The Radical-7 device isolates multiple (7+) wavelengths of light of arterial signals using adaptive filters. It provides continuous noninvasive monitoring of arterial oxygen saturation (RadSpO2), pulse rate (RadPR), carboxyhaemoglobin saturation (SpCO), methaemoglobin saturation (SpMET), total haemoglobin concentration in g/dl (SpHb) and/or respiration rate (RRa). Additionally, Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth Variability Index (PVI), total arterial oxygen content (SpOC), Haematocrit (SpHCT), Signal identification Quality (SIQa), Respiration Indicator (RI) are displayed.The purpose of this prospective study is to investigate the reliability of non-invasive continuously measured SpHb by the Masimo Radical-7® Pulse co-oximeter (Radical 7 device) under steady state conditions by comparison against simultaneously invasive measured arterial haemoglobin concentrations (CoOxHb) in major spine surgery patients, in which high blood loss was expected

Conditions

  • Transcutaneous Continuous Hemoglobin Measurement

Interventions

DEVICE

Pulse CO-Oximetry Hemoglobin measurement transcutaneous

this is an observational Investigation, in which transcutaneous continuous hemoglobin detection using Pulse-CO-Oximetry is compared with co-oximetrically measured Hemoglobin using a blood gas analyzer device

Sponsors & Collaborators

  • Klinik Hirslanden, Zurich

    lead OTHER

Principal Investigators

  • Werner Baulig, MD · Klinik Im Park

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-12-31
Completion
2022-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04506957 on ClinicalTrials.gov