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

NCT02399488 | Unknown

• 1 other identifier: CEIC:47/10
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sphb Haemoglobin in Vivo Validation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• POC Cooximeter bias and limits of agreement

  3 months

• POC Cooximeter bias and limits of agreement

  3 months

• POC Cooximeter Coulter interchangeability

  3 months

Other Outcomes (2)

• Comparison of bias and limits of agreement

  3 months

• Clinical decision making

  3 months

Interventions

Masimo Radical 7 DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Doctor Peset: lead

Study Sites (1)

University Hospital Doctor Peset

Valencia, 46023, Spain

RECRUITING

Related Publications (1)

• 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

  BACKGROUND

Related Links

• Citation link

Study Officials

• Juan Soliveres, MD, PhD

  University Hospital Doctor Peset

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Soliveres, MD, PhD

CONTACT

+34670758871

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 22, 2015
• First Posted: March 26, 2015
• Study Start: February 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 18, 2015

Record last verified: 2015-08

Locations

ES (1)