The Effect of Non-invasive Hemoglobin Measurement in Hip Surgeries

August 25, 2022 updated by: OZCAN PISKIN, MD, Bulent Ecevit University

The Effect of Non-invasive Hemoglobin Measurement on Blood Transfusion and Mortality in Hip Surgeries: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Zonguldak, Turkey, 67600
        • Zonguldak Bülent Ecevit University Medicine Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

General anesthesia undergoing hip surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Device: non-invasive hemoglobin (SpHb)
hemoglobin measuring device
SpHb
Device: non-invasive hemoglobin (SpHb)
hemoglobin measuring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic Stability
Time Frame: during the surgery
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bulent Ecevit University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-24/16/12/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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