The Effect of Non-invasive Hemoglobin Measurement in Hip Surgeries

NCT04785274 | Completed

• 1 other identifier: 2020-24/16/12/2020
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding; Hemorrhage; Hemodynamic Instability

Keywords

Perioperative Bleeding; Mortality; Hemoglobin; Non-invasive monitoring; Transfusion;; SpHb

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Mortality

  until 3 months after surgery

Study Arms (2)

SpHb

Device: non-invasive hemoglobin (SpHb)

Control

Device: non-invasive hemoglobin (SpHb)

Interventions

non-invasive hemoglobin (SpHb) DEVICE

hemoglobin measuring device

Control; SpHb

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

General anesthesia undergoing hip surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bulent Ecevit University Medicine Faculty

Zonguldak, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 5, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)