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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
February 1, 2010
February 2, 2010
October 25, 2016
January 2010
July 2011   (Final data collection date for primary outcome measure)
To evaluate the accuracy of continuous SpHb measurement during hepatic resection compared with standard (invasive) Hb measurement [ Time Frame: during operation ]
To evaluate the accuracy of continuous SpHb measurement during hepatic resection compared with standard (invasive) Hb measurement
Complete list of historical versions of study NCT01060683 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry
Liver Resection and Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
laboratory hemoglobin, Coagulation variables,blood chemistry,Blood gas analysis
Non-Probability Sample
ASA class I and II patients for elective hepatic resection
Elective Hepatic Resection
  • Biological: Hemoglobin determination + NaCl 0.9% bolus
  • Biological: hemoglobin determination + Venofundin bolus
  • Group 1: 15 patients
    for elective hepatic resection
    Intervention: Biological: Hemoglobin determination + NaCl 0.9% bolus
  • Group 2: 15
    for elective hepatic resection
    Intervention: Biological: hemoglobin determination + Venofundin bolus
Vos JJ, Kalmar AF, Struys MM, Wietasch JK, Hendriks HG, Scheeren TW. Comparison of arterial pressure and plethysmographic waveform-based dynamic preload variables in assessing fluid responsiveness and dynamic arterial tone in patients undergoing major hepatic resection. Br J Anaesth. 2013 Jun;110(6):940-6. doi: 10.1093/bja/aes508. Epub 2013 Jan 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01060683
SpHb-001
No
Not Provided
Not Provided
MMRF Struys, University Medical Center Groningen
University Medical Center Groningen
Not Provided
Principal Investigator: Herman G.D. Hendriks, Dr. University Medical Center Groningen
University Medical Center Groningen
August 2009
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