NCT05868447

Unknown

Relationship Between ORI and Blood Transfusion in Spinal Sur...

Bursa Yuksek Ihtisas Training and Research Hospital Source

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Other study identifiers

Sponsor study identifier

2011- KAEK- 25 2022/12-10

Study Type

observational

Estimated enrollment

100

Locations

1 country

Sites

1

Timeline

Study Start

December 15, 2022

Actual (reported)

Primary Completion

June 15, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 15, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 100 participants
Study completion date: June 15, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 15, 2022
Actual (reported)
First Submitted
May 8, 2023
Actual (reported)
First Posted
May 22, 2023
Actual (reported)
Primary Completion
June 15, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 15, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: May 22, 2023
Status Verified: May 2023
Last Update Submitted: May 18, 2023

Conditions

Perioperative Hemorrhage

Keywords

Oxygen reserve indexBlood transfusionvertebrae 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 surgeryProcedure

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.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

Bursa Yuksek Ihtisas Training and Research Hospital
Governmentlead

Study Sites (1)

Bursa Training and Research Hospital

Bursa, 16600, Turkey (Türkiye)

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

Actual (reported)

Primary Completion

June 15, 2023

Estimated (date passed)

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.

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 15, 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05868447
Data provider: ClinicalTrials.gov
Source updated: 2023-05-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:56 UTC

Locations

TR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations