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

Tracking Information

First Received Date ^ICMJE

February 1, 2010

Last Updated Date

February 28, 2012

Start Date ^ICMJE

January 2010

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To evaluate the accuracy of continuous SpHb measurement during hepatic resection compared with standard (invasive) Hb measurement [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01060683 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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. [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Liver Resection and Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

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

Sampling Method

Non-Probability Sample

Study Population

ASA class I and II patients for elective hepatic resection

Condition ^ICMJE

Elective Hepatic Resection

Intervention ^ICMJE

Biological: Hemoglobin determination + NaCl 0.9% bolus
Biological: hemoglobin determination + Venofundin bolus

Study Group/Cohort (s)

Group 1: 15 patients for elective hepatic resection
Intervention: Biological: Hemoglobin determination + NaCl 0.9% bolus
Group 2: 15 patients for elective hepatic resection
Intervention: Biological: hemoglobin determination + Venofundin bolus

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01060683

Other Study ID Numbers ^ICMJE

SpHb-001

Has Data Monitoring Committee

Responsible Party

H.G.D.Hendriks, University Medical Center Groningen

Study Sponsor ^ICMJE

University Medical Centre Groningen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Herman G.D. Hendriks, Dr.

University Medical Centre Groningen

Information Provided By

University Medical Centre Groningen

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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