Sphb Haemoglobin in Vivo Validation Clinical Trial
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.
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | September 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Spain | University Hospital Doctor Peset | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Universitario Doctor Peset |
Spain,
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
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | No |
| Other | Clinical decision making | Error grid analysis plot | 3 months | No |
| Primary | Central coulter bias and limits of agreement | Bias and limits of agreement of SpHb compared to the central laboratory coulter | 3 months | No |
| Primary | 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 | No |
| Secondary | POC Cooximeter bias and limits of agreement | Bias and limits of agreement of SpHb compared to the POC cooximeter | 3 months | No |
| Secondary | 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 | No |
| Secondary | POC Cooximeter Coulter interchangeability | Bias and limits of agreement of POC Cooximeter Hb determination compared to the central laboratory coulter | 3 months | No |