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Validation of Continuous Noninvasive Haemoglobin Monitoring by the Radical 7 Pulse CO-Oximetry Monitor After in Vivo Adjustment.

NCT02399488 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2015-08-18

No results posted yet for this study

Summary

Continuous haemoglobin determination could improve the outcomes of several patients in risk of bleeding during surgery. An in vivo calibration has been introduced to the device after our team found its need. The uncalilbrated validation of the Masimo Radical 7 continuous haemoglobin monitor has been made in various papers, although it has been compared to point of care devices, thus introducing an error as such point of care devices although validated for haemoglobin determination, are not as accurate as the gold standard. The validation of the gold standard calibrated device has not been described yet.

When compared to the accepted gold standard (cyanmethemoglobin method, Coulter), accuracy and precision of the continuous haemoglobin monitor could be good enough to be used interchangeably with the gold standard.

Conditions

  • Sphb Haemoglobin in Vivo Validation

Interventions

DEVICE

Masimo Radical 7

Simultaneous determination of haemoglobin with the continuous haemoglobin monitor, the central lanboratory coulter and a POC:

Sponsors & Collaborators

  • Hospital Universitario Doctor Peset

    lead OTHER

Principal Investigators

  • Juan Soliveres, MD, PhD · University Hospital Doctor Peset

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-06-30
Completion
2015-09-30

Countries

  • Spain

Study Locations

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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 NCT02399488 on ClinicalTrials.gov