- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01060683
Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry
April 16, 2024 updated by: University Medical Center Groningen
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Groningen, Netherlands, 9700RB
- University Medical Center Groningen,University of Groningen, the Netherlands
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
ASA class I and II patients for elective hepatic resection
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1: 15 patients
for elective hepatic resection
|
|
Group 2: 15
for elective hepatic resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the accuracy of continuous SpHb measurement during hepatic resection compared with standard (invasive) Hb measurement
Time Frame: during operation
|
during operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
during operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Herman G.D. Hendriks, Dr., University Medical Center Groningen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
February 1, 2010
First Submitted That Met QC Criteria
February 1, 2010
First Posted (Estimated)
February 2, 2010
Study Record Updates
Last Update Posted (Actual)
April 18, 2024
Last Update Submitted That Met QC Criteria
April 16, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SpHb-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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