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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664777
• Other study ID #: Inonu universitesi
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: April 2022
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 15, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

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)

Locations

Country	Name	City	State
Turkey	Inonu Univercity	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHb	Correlation between non-invazive Hb measurement (measured by the masimo monitoring platform) and laboratuar Hb level.	Up to 14 weeks
Secondary	CPIS	Correlation between Perfusion index (measured by the masimo monitoring platform) and surgery	Up to 14 weeks