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

Sponsor
Inonu University (Other)
Overall Status
Completed
CT.gov ID
NCT04664777
Collaborator
(none)
55
1
4.5
12.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
55 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Intraoperative Correlation of Non Invasive Hemoglobin (SpHb) Measurement With Laboratory Hemoglobin Measurement in Living Liver Donors
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Nov 15, 2020
Actual Study Completion Date :
Dec 15, 2020

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. CHb [Up to 14 weeks]

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

Secondary Outcome Measures

  1. CPIS [Up to 14 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inonu Univercity Malatya Turkey 44280

Sponsors and Collaborators

  • Inonu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yusuf Ziya ÇOLAK, Asst. Prof. Yusuf Ziya Çolak, Inonu University
ClinicalTrials.gov Identifier:
NCT04664777
Other Study ID Numbers:
  • Inonu universitesi
First Posted:
Dec 11, 2020
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Yusuf Ziya ÇOLAK, Asst. Prof. Yusuf Ziya Çolak, Inonu University

Study Results

No Results Posted as of Apr 5, 2022