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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060683
First Posted: February 2, 2010
Last Update Posted: October 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MMRF Struys, University Medical Center Groningen
  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 MMRF Struys, University Medical Center 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 ]

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 ]

Biospecimen Retention:   Samples Without DNA
laboratory hemoglobin, Coagulation variables,blood chemistry,Blood gas analysis

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
for elective hepatic resection
Biological: hemoglobin determination + Venofundin bolus

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060683


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MMRF Struys, Prof.dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01060683     History of Changes
Other Study ID Numbers: SpHb-001
First Submitted: February 1, 2010
First Posted: February 2, 2010
Last Update Posted: October 25, 2016
Last Verified: August 2009

Keywords provided by MMRF Struys, University Medical Center Groningen:
hemoglobin
Coagulation variables
blood chemistry
Blood gas analysis