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

NCT04664777 | Completed FDA Device

• 1 other identifier: Inonu universitesi
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

hemoglobin level; Pulse CO-Oximetry; intraoperative

Outcome Measures

Primary Outcomes (1)

• CHb

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

  Up to 14 weeks

Secondary Outcomes (1)

• CPIS

  Up to 14 weeks

Study Arms (1)

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

Interventions

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)

Group1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adult patients undergoing hepatectomy with general anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu Univercity

Malatya, 44280, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Yusuf Ziya Çolak

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 11, 2020
• Study Start: August 1, 2020
• Primary Completion: November 15, 2020
• Study Completion: December 15, 2020
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)