Elective Hepatic Resection Clinical Trial
Official title:
Liver Resection and Non-invasive Measurement of Hemoglobin Concentration With Pulse Co-oximetry
| NCT number | NCT01060683 |
| Other study ID # | SpHb-001 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2010 |
| Est. completion date | July 2011 |
| Verified date | April 2024 |
| Source | University Medical Center Groningen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | July 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | University Medical Center Groningen,University of Groningen, the Netherlands | Groningen |
| Lead Sponsor | Collaborator |
|---|---|
| University Medical Center Groningen |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the accuracy of continuous SpHb measurement during hepatic resection compared with standard (invasive) Hb measurement | during operation | ||
| Secondary | 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. | during operation |