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OpenTrials
Completed

NCT Number: NCT04785274

The Effect of Non-invasive Hemoglobin Measurement in Hip Surgeries

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zonguldak Bulent Ecevit University Medicine Faculty

Zonguldak, 67600, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-invasive hemoglobin (SpHb)

Device

hemoglobin measuring device

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mortality

    Time frame: until 3 months after surgery

    to compare the effects of transfusion results on mortality.

Sponsors and collaborators

Lead sponsor

Bulent Ecevit University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2021
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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