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Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01060683
First received: February 1, 2010
Last updated: February 28, 2012
Last verified: August 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the accuracy of continuous SpHb measurement ( Rainbow DCI, Masimo, Irvine Ca, USA) compared to the current method of monitoring (blood sampling), both during phases of hemoconcentration and hemodilution.


Condition Intervention
Elective Hepatic Resection
 Biological: Hemoglobin determination + NaCl 0.9% bolus
Biological: hemoglobin determination + Venofundin bolus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Liver Resection and Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • To evaluate the accuracy of continuous SpHb measurement during hepatic resection compared with standard (invasive) Hb measurement [ Time Frame: during operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the effect of a bolus of crystalloid on SpHb level will be compared to the effect of a bolus of colloid on the SpHb level. [ Time Frame: during operation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

laboratory hemoglobin, Coagulation variables,blood chemistry,Blood gas analysis


Estimated Enrollment: 30
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1: 15 patients for elective hepatic resection Biological: Hemoglobin determination + NaCl 0.9% bolus
Group 2: 15 patients for elective hepatic resection Biological: hemoglobin determination + Venofundin bolus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ASA class I and II patients for elective hepatic resection

Criteria

Inclusion Criteria:

  • All patients: Age > 18 years
  • ASA class I and II patient requiring hepatic resection

Exclusion Criteria:

  • Patient refusal
  • Patients with a perioperative blood loss exceeding 5ml/kg
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060683

Locations
Netherlands
University Medical Center Groningen,University of Groningen, the Netherlands
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Herman G.D. Hendriks, Dr. University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: H.G.D.Hendriks, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01060683     History of Changes
Other Study ID Numbers: SpHb-001
Study First Received: February 1, 2010
Last Updated: February 28, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
hemoglobin
Coagulation variables
blood chemistry
Blood gas analysis

ClinicalTrials.gov processed this record on June 18, 2013