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

Completed

• Conditions: Anesthesia
• Interventions: Device: Masimo Model RDS7A

• Registration Number: NCT04664777
• Lead Sponsor: Inonu University

Brief Summary

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.

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 Timeline

• Study Start: 2020-08-01
• Primary Completion: 2020-11-15
• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-12-07
• Study First Posted: 2020-12-11
• Study Completion: 2020-12-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1	Masimo Model RDS7A	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
CPIS	Up to 14 weeks	Correlation between Perfusion index (measured by the masimo monitoring platform) and surgery

Trial Locations

Locations (1)

Inonu Univercity; 🇹🇷 Malatya, Turkey