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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University Medical Centre Groningen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 31, 2014