Clinical trial NCT02399488: Validation of Continuous Noninvasive Haemoglobin Monitoring by the Radical 7 Pulse CO-Oximetry Monitor After in Vivo Adjustment.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sphb Haemoglobin in Vivo Validation
Lead sponsor: Hospital Universitario Doctor Peset
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients scheduled to any surgery of at least three hours of duration.

Brief 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.

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Two blood samples will be withdrawn at the same time from an arterial line, one for the central laboratory and the other one for the POC device.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 A maximum of 20 samples will be withdrawn per patient.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.

Eligibility criteria: 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.

Primary outcomes:
measure: Central coulter bias and limits of agreement
timeFrame: 3 months
measure: Central coulter bias and limits of agreement after in vivo calibration
timeFrame: 3 months
Secondary outcomes:
measure: POC Cooximeter bias and limits of agreement
timeFrame: 3 months
measure: POC Cooximeter bias and limits of agreement
timeFrame: 3 months
measure: POC Cooximeter Coulter interchangeability
timeFrame: 3 months
Other outcomes:
measure: Comparison of bias and limits of agreement
timeFrame: 3 months
measure: Clinical decision making
timeFrame: 3 months
Locations:
city: Valencia
country: Spain
facility: University Hospital Doctor Peset
Study officials:
affiliation: University Hospital Doctor Peset
name: Juan Soliveres, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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