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

Validation of a Continuous Noninvasive Haemoglobin Determination Monitor (Radical 7 Pulse CO-Oximeter, SpHb) Compared to the Central Laboratory Coulter (LabHb) and a Point of Care (POC) Invasive Cooximeter (COoxHb) After in Vivo Adjustment.

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.

Study Overview

• Status: Unknown
• Conditions: Sphb Haemoglobin in Vivo Validation
• Intervention / Treatment: Device: Masimo Radical 7

Detailed Description

Continuous haemoglobin determination could improve the outcomes of several patients in risk of bleeding during surgery.

The in vivo calibration has not been adjusted to the gold standard haemoglobin determination in the literature yet.

Two blood samples will be withdrawn at the same time from an arterial line, one for the central laboratory and the other one for the POC device. At the same exact time the SpHb measurement will be recorded. At least eight samples are expected per patient. A maximum of 20 samples will be withdrawn per patient.

To compare bias, precision and limits of agreement among SpHb, LabHb and COoxHb the Bland Altman method will be used with multiple observations per subject when the true value varies. An error grid analysis will be made to know how it could affect to clinical decision making.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46023
    • Recruiting
    • University Hospital Doctor Peset
    • Contact: Juan Soliveres, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled to any surgery of at least three hours of duration.

Description

Inclusion Criteria:

• Adult patients.
• Surgery duration of at least two hours.
• Patients scheduled to surgery under general anaesthesia and muscle relaxation.
• Radial arterial line needed for blood pressure control or other reason not related to the study.

Exclusion Criteria:

• Radial arterial line not indicated / not possible to place.
• Sampling difficult or impossible.
• Need to reposition arterial line arm during surgery.
• Any illness that could influence the haemoglobin measurement.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central coulter bias and limits of agreement	Bias and limits of agreement of SpHb compared to the central laboratory coulter	3 months
Central coulter bias and limits of agreement after in vivo calibration	Bias and limits of agreement of SpHb compared to the central laboratory coulter after in vivo Radical 7 calibration	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POC Cooximeter bias and limits of agreement	Bias and limits of agreement of SpHb compared to the POC cooximeter	3 months
POC Cooximeter bias and limits of agreement	Bias and limits of agreement compared to the POC cooximeter after in vivo Radical 7 calibration	3 months
POC Cooximeter Coulter interchangeability	Bias and limits of agreement of POC Cooximeter Hb determination compared to the central laboratory coulter	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of bias and limits of agreement	Comparison of bias and limits of agreement among central laboratory, POC cooximeter and SpHb continuous monitor.	3 months
Clinical decision making	Error grid analysis plot	3 months

Collaborators and Investigators

• Sponsor: Hospital Universitario Doctor Peset
• Investigators: Principal Investigator: Juan Soliveres, MD, PhD, University Hospital Doctor Peset

Publications and helpful links

General Publications

• Soliveres J, Balaguer J, Estruch M, Sánchez A, Sánchez J. Validation of Continuous and Noninvasive Hemoglobin Monitoring from Pulse CO-Oximetry during Surgery. 2010 Annual Meeting of the American Society Anesthesiologists

Helpful Links

• Citation link

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: March 22, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Estimate): August 18, 2015
• Last Update Submitted That Met QC Criteria: August 16, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CEIC:47/10