Correlation of Non Invasive Hemoglobin Measurement With L... | NCT04664777

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

NCT04664777

Sponsor

Inonu University

Status

Completed

Last Update Posted

Apr 5, 2022Actual

Enrollment

55Actual

Phase

Not provided

Conditions

Anesthesia

Interventions

Masimo Model RDS7A

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Nov 15, 2020Actual

Completion Date

Dec 15, 2020Actual

First Submitted Date

Nov 30, 2020

First Submission Date that Met QC Criteria

Dec 7, 2020

First Posted Date

Dec 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2022

Last Update Posted Date

Apr 5, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yusuf Ziya ÇOLAK, Asst. Prof. Yusuf Ziya Çolak, Inonu UniversityPrincipal Investigator

Lead Sponsor

Inonu UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inonu Univercity		Malatya		44280	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided