Correlation of Non Invasive Hemoglobin Measurement With Laboratory Hemoglobin Measurement in Living Liver Donors

Intraoperative Correlation of Non Invasive Hemoglobin (SpHb) Measurement With Laboratory Hemoglobin Measurement in Living Liver Donors

Pulse CO-Oximetry (Masimo Corp, Irvine, CA, USA) is a method that allows non-invasive continuous hemoglobin (Hb) measurement. This technology measures continuous Hb with a multi-wavelength spectrophotometric fingertip sensor.

Aim of investigators in this study is to make continuous Hb measurement with Pulse CO-Oximetry method in living liver donors, to compare these measurements with the laboratory results routinely taken during the operation, to determine the level of correlation for this patient group.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Device: Masimo Model RDS7A

Detailed Description

Continuous Hb measurement with Pulse CO-Oximetry (SpHb) can be usefull for living liver donor and improve the quality of intraoperative care. This technology measures continuous Hb with a multi-wavelength spectrophotometric fingertip sensor.

The perfusion index (PI) is the ratio of the pulsatile blood flow to the nonpulsatile or static blood in peripheral tissue. Perfusion Index thus represents a noninvasive measure of peripheral perfusion that can be continuously and noninvasively obtained from a pulse oximeter. Changes in PI can also occur as a result of local vasoconstriction (decrease in PI) or vasodilatation (increase in PI) in the skin at the monitoring site. These changes occur with changes in the volumeof oxygenated bloodflow in the skin microvasculature. PI values can change due to surgical process and may affect SpHb measurement.

Aim of investigators in this study is to make continuous Hb measurement with Pulse CO-Oximetry method in living liver donors before and after surgery incision, to compare these measurements with the laboratory results routinely taken during the operation, to determine the level of correlation for this patient group.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44280
    • Inonu Univercity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

According to ASA physical status classification system ASA 1-2 cases scheduled for hepatectomy for liver transplantation

Description

Inclusion Criteria:

• Adult patients undergoing hepatectomy with general anesthesia

Exclusion Criteria:

• Patient's lack of consent, essential data missing, patient participating in other research projects, drug allergy, anesthetic complication story, excessive surgical bleeding, presence of disease that impairs peripheral circulation, use of vasoactive agents.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Group1; Living liver donors who operated between 1 August and 15 november: After anesthesia induction and surgical field sterilization, before surgical incision; blood sample will be taken, SpHb, PI and vital measurements (SpO2, Heart rate, NIBP, body temperature) will be recorded. After the surgical procedure is over and before the patient is awakened from anesthesia; blood sample will be taken, SpHb, PI and vital measurements (SpO2, Heart rate, NIBP, body temperature) will be recorded.

Device: Masimo Model RDS7A; Masimo monitoring platform equipped with Radical-7 Pulse CO-Oximeter fingertip probe for measurement non-invazive hemoglobin level (SpHb) an perfusion index (PI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CHb	Correlation between non-invazive Hb measurement (measured by the masimo monitoring platform) and laboratuar Hb level.	Up to 14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CPIS	Correlation between Perfusion index (measured by the masimo monitoring platform) and surgery	Up to 14 weeks

Collaborators and Investigators

• Sponsor: Inonu University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): November 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: hemoglobin level; intraoperative; Pulse CO-Oximetry
• Other Study ID Numbers: Inonu universitesi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes