The Effect of Non-invasive Hemoglobin Measurement in Hip... | NCT04785274

Studies
The Effect of Non-invasive Hemoglobin Measurement in Hip Surgeries

NCT04785274

Sponsor

Bulent Ecevit University

Status

Completed

Last Update Posted

Aug 26, 2022Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Bleeding
Hemorrhage
Hemodynamic Instability

Interventions

non-invasive hemoglobin (SpHb)

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

Aug 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

Jan 1, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Mar 3, 2021

First Submission Date that Met QC Criteria

Mar 3, 2021

First Posted Date

Mar 5, 2021Actual

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

Aug 25, 2022

Last Update Posted Date

Aug 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Bleeding is one of the most important causes of mortality and morbidity in patients.

Hb levels are the most prevalently utilized monitoring parameter in hemorrhagic patients in the hemodynamic sense. Hemoglobin determination is studied at laboratories along with blood gasses or complete blood analysis. Recently, non-invasive techniques where measurement is made from the fingertips have been offered for use. One of these techniques is non-invasive hemoglobin (SpHb) measurement. SpHb is used as a trend monitor. Based on the severity of bleeding, the compensatory mechanisms of patients may be disrupted. This situation may lead to lower levels of toleration of anemia during bleeding. The relationship between blood transfusion and mortality is under debate.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SpHb			Device: non-invasive hemoglobin (SpHb)
Control			Device: non-invasive hemoglobin (SpHb)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non-invasive hemoglobin (SpHb)	Device	hemoglobin measuring device	Control SpHb

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemodynamic Stability	to compare blood transfusion decisions made with SpHb measurement values and with conventional methods in patient who would receive hip surgery.	during the surgery

Secondary Outcomes

Measure	Description	Time Frame
Mortality	to compare the effects of transfusion results on mortality.	until 3 months after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-60 years old
General anesthesia undergoing hip surgery
American society of anesthesiology (ASA) scores I-II-III

Exclusion Criteria:

Receiving inotropic support
Uncontrolled diabetes
Arrhythmia
Hypothermia
Hyperbilirubinemia
Jaundice
Dark skin pigmentation
Without voluntary consent
Hypovolemia,
hypotension,
sepsis,
blood diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

General anesthesia undergoing hip surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zonguldak Bulent Ecevit University Medicine Faculty		Zonguldak		67600	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

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided