Relationship Between ORI and Blood Transfusion in Spinal Surgery

NCT05868447 | Unknown

• 1 other identifier: 2011- KAEK- 25 2022/12-10
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Concerns about the necessity and risks of blood transfusions have led to the search for new noninvasive monitoring methods. Oxygen reserve index (ORI), one of them, is a dimensionless index ranging from 0.00 (no reserve) to 1.00 (maximum reserve) according to oxygenation reserve status, and it is also a non-invasive and continuous measurement parameter. Some studies have examined ORi as an indicator for early detection of hypoxemia. There are reports in the literature that ORi and Pa02 values measured noninvasively during surgery are early precursors for desaturation and hypoxia.Researces aimed to investigate the relationship between perioperative blood transfusions and ORI in vertebral stabilization surgeries performed by the same surgical team in our clinic.

Conditions

Perioperative Hemorrhage

Keywords

Oxygen reserve index; Blood transfusion; vertebrae stabilization surgery

Outcome Measures

Primary Outcomes (1)

• Intraoperative ORI values

  Monitoring ORI values at the beginning of surgery and values measured every 15 minutes during surgery

  Perioperative process (2-5 hours)

Secondary Outcomes (1)

• Perioperative blood transfusion prediction

  Perioperative process (2-5 hours)

Interventions

Stabilization surgery PROCEDURE

hourly blood gas analysis and hemoglobin and hematocrit control and blood transfusion will be performed when necessary If a low pO2 value is observed in the blood gas, the fi02 values or fresh gas flow will be increased.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elective patients planned stabilization surgery

You may qualify if:

• Patients over 18 years of age in ASA I-III risk class
• Patients who will undergo vertebral stabilization surgery at 3 levels or more under general anesthesia (lumbar disc herniation, lumbar spinal stenosis, lumbar spondylolisthesis and other lumbar spine pathologies)
• who are expected to lose \>500 ml of blood
• Patients who require arterial catheter placement for continuous monitoring of blood pressure and/or analysis of arterial blood gas during surgery

You may not qualify if:

• Patients with coagulation disorders, thrombocytopenia, liver and kidney disease
• Patients receiving regular anticoagulant and antiplatelet therapy
• Patients who will undergo revision surgery
• Patients who will undergo surgery due to spinal tumor or infection
• Patients with perioperative tranexamic acid and/or antifibrinolytic use
• Patients with preoperative hemoglobin values \<12 g/dl in women and \<13 g/dl in men or patients with preoperative anemia due to hemoglobinopathies (e.g. thalassemia, sickle cell disease anemia)
• Patients with congestive heart failure
• Inability to attach the sensor due to deformity of the fingers
• Inability to attach the sensor due to hypoperfusion of the fingers: thalassemia, sickle cell disease anemia)
• Patients with congestive heart failure
• Inability to wear the sensor due to deformity of the fingers
• Patients who would show an inadequate signal due to hypoperfusion of the fingers were excluded.

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Training and Research Hospital

Bursa, 16600, Turkey (Türkiye)

Location

Study Officials

• Asiye A Demirel, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 22, 2023
• Study Start: December 15, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)