Perioperative HemorrhageNCT05868447
Relationship Between ORI and Blood Transfusion in Spinal Surgery
An observational study of Perioperative Hemorrhage, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Hemorrhage
- What is being tested?
- Stabilization surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 15 Jun 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elective patients planned stabilization surgery
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Training and Research Hospital
Bursa, 16600
About this study
Official title: Investigation of the Relationship Between Perioperative Blood Transfusion and Intraoperatively Monitored Oxygen Reserve Index (ORI) in Patients Scheduled for Vertebral Stabilization Surgery
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.
Read the detailed description
With the increase in the elderly population in the world, the incidence of vertebral deformities is increasing and vertebral surgery has become one of the most commonly performed surgeries. Blood loss in vertebral and spinal canal deformity surgeries varies according to the surgical procedure, duration of operation and type of anesthesia. With the increase in blood loss, blood and blood product transfusion also increases. Although many technical and pharmacological methods have been applied to reduce blood transfusion in surgical patients, there is still no consensus on when to transfuse, and there are still institutional and individual differences in transfusion practices. In the literature, there are studies showing that some centers never use blood for the same surgery in patients, while in other centers blood is almost always used [4]. This has led to the comment that "Blood transfusion is a practice that takes place according to the physician, not the patient." The World Health Organization (WHO) defines anemia as hemoglobin (Hb) concentration <13 g/dl for men and <12 g/dl for women. Although these Hb concentrations stated in the literature try to define the lowest acceptable hemoglobin, transfusion practices are based on multiple physiologic parameters (tachycardia, hypotension, ST segment changes) rather than an isolated laboratory measurement (Hb and hematocrit values), The decision to transfuse blood is known to be difficult to standardize as it has to be made taking into account the need for increased oxygen extraction rate, new-onset wall motion abnormalities on transesophageal echocardiography, cardiac output and oxygen content of arterial blood, central venous oxygen saturation, base deficit, lactate level, etc.). The decision to transfuse blood is based on the hope of increasing tissue oxygen delivery (DO2), followed by cellular oxygenation. Improving DO2 has been shown to reduce both morbidity and mortality in the perioperative period. Tailoring DO2 to O2 consumption using specific targets seems promising. The common criterion used to start blood transfusion therapy is to determine the Hb level and to show that the DO2 has fallen to the critical Hb level, which is assumed to be compromised. With this view triggered by the Hb level detected at the critical level, transfusion is performed and it is seen that the Hb level is increased to a safe level after transfusion. Although it can be easily demonstrated that transfusion therapy increases Hb level and consequently DO2, it requires further research to determine how this treatment reflects on the general oxygen supply/consumption balance. Indeed, for this purpose, monitoring of mixed central venous oxygen saturation (SvO2) is a prerequisite. This method, which requires a pulmonary artery catheter, is currently used in very limited situations and indications and central venous saturation (ScvO2) value is generally used instead of SvO2.
Anesthesia management of the patients included in the study and the interventional procedures to be performed will be decided by the responsible anesthesiologist.
The initial ORI value of the patient will be determined as PO2 value between 100-120 mmHg in arterial blood gas (ABG) and will be recorded on the case report form every 15 minutes. The preoperative Hb value will also be recorded on the case report form, and in patients with intraoperative expected blood loss >500 ml and for whom blood transfusion is foreseen, the hemoglobin value and ORI value will be recorded by the responsible anesthesiologist at the time of the indication of erythrocyte transfusion. Accordingly, the relationship between the initial ORI value and the ORI value at the time of the decision for erythrocyte transfusion will be examined.
- Conditions
- Perioperative Hemorrhage
- Being tested
- Stabilization surgery
- Keywords
- Oxygen reserve index, Blood transfusion, vertebrae stabilization surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilization surgeryProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative ORI values
Monitoring ORI values at the beginning of surgery and values measured every 15 minutes during surgery
Measured: Perioperative process (2-5 hours)
Secondary outcomes (1)
Perioperative blood transfusion prediction
To measure the ORI values from the beginning of the case until the end of the case with a finger probe from the patient's finger with the Oxygen reserve index (ORI) monitoring device in patients who will undergo vertebral stabilization surgery and to determine how much the ORI value decreases compared to the beginning of surgery when the patient bleeds and to answer the question of whether the decrease can predict the erythrocyte transfusion.
Measured: Perioperative process (2-5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start15 Dec 2022
- Primary completion15 Jun 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Asiye Demirel, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Asiye A Demirel, MD, Principal investigator, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868447
- Sponsor's protocol ID
- 2011- KAEK- 25 2022/12-10
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Perioperative Blood Transfusion and Intraoperatively Monitored Oxygen Reserve Index (ORI) in Patients Scheduled for Vertebral Stabilization Surgery
- ClinicalTrials.gov ID
- NCT05868447
- Acronym / sponsor ID
- 2011- KAEK- 25 2022/12-10
- Conditions
- Perioperative Hemorrhage
- Keywords
- Oxygen reserve index, Blood transfusion, vertebrae stabilization surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
With the increase in the elderly population in the world, the incidence of vertebral deformities is increasing and vertebral surgery has become one of the most commonly performed surgeries. Blood loss in vertebral and spinal canal deformity surgeries varies according to the surgical procedure, duration of operation and type of anesthesia. With the increase in blood loss, blood and blood product transfusion also increases. Although many technical and pharmacological methods have been applied to reduce blood transfusion in surgical patients, there is still no consensus on when to transfuse, and there are still institutional and individual differences in transfusion practices. In the literature, there are studies showing that some centers never use blood for the same surgery in patients, while in other centers blood is almost always used [4]. This has led to the comment that "Blood transfusion is a practice that takes place according to the physician, not the patient." The World Health Organization (WHO) defines anemia as hemoglobin (Hb) concentration <13 g/dl for men and <12 g/dl for women. Although these Hb concentrations stated in the literature try to define the lowest acceptable hemoglobin, transfusion practices are based on multiple physiologic parameters (tachycardia, hypotension, ST segment changes) rather than an isolated laboratory measurement (Hb and hematocrit values), The decision to transfuse blood is known to be difficult to standardize as it has to be made taking into account the need for increased oxygen extraction rate, new-onset wall motion abnormalities on transesophageal echocardiography, cardiac output and oxygen content of arterial blood, central venous oxygen saturation, base deficit, lactate level, etc.). The decision to transfuse blood is based on the hope of increasing tissue oxygen delivery (DO2), followed by cellular oxygenation. Improving DO2 has been shown to reduce both morbidity and mortality in the perioperative period. Tailoring DO2 to O2 consumption using specific targets seems promising. The common criterion used to start blood transfusion therapy is to determine the Hb level and to show that the DO2 has fallen to the critical Hb level, which is assumed to be compromised. With this view triggered by the Hb level detected at the critical level, transfusion is performed and it is seen that the Hb level is increased to a safe level after transfusion. Although it can be easily demonstrated that transfusion therapy increases Hb level and consequently DO2, it requires further research to determine how this treatment reflects on the general oxygen supply/consumption balance. Indeed, for this purpose, monitoring of mixed central venous oxygen saturation (SvO2) is a prerequisite. This method, which requires a pulmonary artery catheter, is currently used in very limited situations and indications and central venous saturation (ScvO2) value is generally used instead of SvO2.
Anesthesia management of the patients included in the study and the interventional procedures to be performed will be decided by the responsible anesthesiologist.
The initial ORI value of the patient will be determined as PO2 value between 100-120 mmHg in arterial blood gas (ABG) and will be recorded on the case report form every 15 minutes. The preoperative Hb value will also be recorded on the case report form, and in patients with intraoperative expected blood loss >500 ml and for whom blood transfusion is foreseen, the hemoglobin value and ORI value will be recorded by the responsible anesthesiologist at the time of the indication of erythrocyte transfusion. Accordingly, the relationship between the initial ORI value and the ORI value at the time of the decision for erythrocyte transfusion will be examined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elective patients planned stabilization surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stabilization surgeryhourly 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. | Procedure or surgery | – |
Primary outcome
Intraoperative ORI values
Time frame: Perioperative process (2-5 hours)
Monitoring ORI values at the beginning of surgery and values measured every 15 minutes during surgery
1 secondary outcome
Perioperative blood transfusion prediction
Time frame: Perioperative process (2-5 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asiye A Demirel, MD principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Hemorrhage, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative ORI values (time frame: Perioperative process (2-5 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.