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Completed

NCT Number: NCT04664777

Correlation of Non Invasive Hemoglobin 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Inonu Univercity

Malatya, 44280, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Masimo Model RDS7A

Device

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

Primary outcomes

  1. CHb

    Time frame: Up to 14 weeks

    Correlation between non-invazive Hb measurement (measured by the masimo monitoring platform) and laboratuar Hb level.

Secondary outcomes

  1. CPIS

    Time frame: Up to 14 weeks

    Correlation between Perfusion index (measured by the masimo monitoring platform) and surgery

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2020
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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