Lumbar Spine SurgeryNCT07549165
IVC Collapsibility Index in Lumbar Stabilization Surgery
An observational study of Lumbar Spine Surgery and Hemodynamic Changes, run by Trabzon Kanuni Education and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to evaluate perioperative hemodynamic changes using the inferior vena cava (IVC) collapsibility index in patients undergoing lumbar stabilization surgery under general anesthesia. The IVC diameter and collapsibility index will be measured using ultrasonography at predefined perioperative time points. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spine Surgery, Hemodynamic Changes, Intravascular Volume Status
- How many people
- 128 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 15 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) scheduled for elective lumbar spine stabilization surgery under general anesthesia at Trabzon University Faculty of Medicine Hospital will be included in this study. All participants will be classified as ASA physical status I-II-III and will undergo surgery in the prone position. Inferior vena cava (IVC) diameter and collapsibility index will be measured using ultrasonography at predefined perioperative time points.
Who may be able to join
- Age ≥ 18 years
- Patients classified as ASA physical status I-II-III
- Patients scheduled for elective lumbar spine stabilization surgery under general anesthesia
- Ability to obtain adequate inferior vena cava (IVC) ultrasonographic imaging
- Provision of written informed consent
Who cannot join
- Age younger than 18 years
- Emergency surgery
- American Society of Anesthesiologists (ASA) physical status IV
- Patients undergoing revision lumbar stabilization surgery
- Baseline systolic blood pressure >180 mmHg or <90 mmHg
- Heart failure with ejection fraction (EF) <40%
Show all 13Show fewer
- Pulmonary artery pressure (PAP) >40 mmHg
- Presence of intra-abdominal mass, ascites, or increased intra-abdominal pressure
- Body mass index (BMI) >30 kg/m²
- Pregnancy
- Patients with neurological or psychiatric disorders
- Inability to obtain adequate inferior vena cava (IVC) ultrasonographic imaging
- Refusal to provide written informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Trabzon University Faculty of Medicine Kanunı Training and Research Hospital ,Trabzon
Trabzon, 61080
- Recruiting
Trabzon University Faculty of Medicine, Kanuni Training and Research Hospital
Trabzon, 61080
Recep Erin, MD, +905304699135, erinrecep@gmail.com
About this study
Official title: Hemodynamic Assessment Using the Inferior Vena Cava Collapsibility Index in Patients Undergoing Lumbar Stabilization Surgery
This study aims to evaluate perioperative hemodynamic changes using the inferior vena cava (IVC) collapsibility index in patients undergoing lumbar stabilization surgery under general anesthesia. The IVC diameter and collapsibility index will be measured using ultrasonography at predefined perioperative time points. Hemodynamic parameters such as blood pressure and heart rate will also be recorded. The study seeks to determine whether the IVC collapsibility index can be used as a non-invasive indicator of intravascular volume status and hemodynamic changes during lumbar spine surgery.
Read the detailed description
his prospective study aims to evaluate perioperative hemodynamic changes using the inferior vena cava (IVC) collapsibility index in patients undergoing lumbar stabilization surgery under general anesthesia in the prone position. The inferior vena cava diameter will be measured using ultrasonography at different perioperative time points, including the preoperative period, after induction of anesthesia, and before extubation.
The IVC diameter and collapsibility index will be recorded and analyzed to assess changes in intravascular volume status during the perioperative period. In addition to ultrasonographic measurements, hemodynamic parameters such as blood pressure and heart rate will be monitored and recorded.
The study aims to investigate whether the IVC collapsibility index can be used as a non-invasive indicator of intravascular volume status and perioperative hemodynamic changes in patients undergoing lumbar spine surgery.
- Keywords
- Inferior Vena Cava • IVC Collapsibility Index • Lumbar Stabilization Surgery • Hemodynamic Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Lumbar Spine Surgery | Adult patients undergoing elective lumbar spine stabilization surgery under general anesthesia in the prone position. Inferior vena cava (IVC) diameter and collapsibility index will be measured using ultrasonography at predefined perioperative time points (preoperative period, after induction of anesthesia, and before extubation). Hemodynamic parameters such as blood pressure and heart rate will also be recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inferior Vena Cava Collapsibility Index
The inferior vena cava (IVC) collapsibility index will be measured using ultrasonography at predefined perioperative time points (preoperative period, after induction of general anesthesia, and before extubation) in patients undergoing elective lumbar spine surgery in the prone position.
Measured: Perioperative period (preoperative assessment, after anesthesia induction, and before extubation)
Secondary outcomes (1)
Intraoperative Hypotension Incidence
The occurrence of intraoperative hypotension during lumbar spine surgery under general anesthesia will be recorded. Hypotension will be defined as mean arterial pressure below 65 mmHg.
Measured: During the intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start15 Feb 2026
- Primary completion15 Feb 2026
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine SurgeryStudies 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
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trabzon Kanuni Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyma Yüksel Ayar, Trabzon Kanuni Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549165
- Sponsor's protocol ID
- 10496660-2026/25031
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the dataset contains patient-level clinical information collected during routine clinical care. Data may be available from the investigators upon reasonable request and with approval from the institutional ethics committee.
Publications
Yoon HK, Lee HC, Chung J, Park HP. Predictive Factors for Hypotension Associated With Supine-to-Prone Positional Change in Patients Undergoing Spine Surgery. J Neurosurg Anesthesiol. 2020 Apr;32(2):140-146. doi: 10.1097/ANA.0000000000000565.
PubMed 30475290Lee S, Kim DY, Han J, Kim K, You AH, Kang HY, Park SW, Kim MK, Kim JE, Choi JH. Hemodynamic changes in the prone position according to fluid loading after anaesthesia induction in patients undergoing lumbar spine surgery: a randomized, assessor-blind, prospective study. Ann Med. 2024 Dec;56(1):2356645. doi: 10.1080/07853890.2024.2356645. Epub 2024 May 24.
PubMed 38794845
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Assessment Using the Inferior Vena Cava Collapsibility Index in Patients Undergoing Lumbar Stabilization Surgery
- ClinicalTrials.gov ID
- NCT07549165
- Acronym / sponsor ID
- 10496660-2026/25031
- Keywords
- Inferior Vena Cava • IVC Collapsibility Index • Lumbar Stabilization Surgery • Hemodynamic Monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Trabzon Kanuni Education and Research HospitalUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 23 Apr 2026 (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.
This study aims to evaluate perioperative hemodynamic changes using the inferior vena cava (IVC) collapsibility index in patients undergoing lumbar stabilization surgery under general anesthesia. The IVC diameter and collapsibility index will be measured using ultrasonography at predefined perioperative time points. Hemodynamic parameters such as blood pressure and heart rate will also be recorded. The study seeks to determine whether the IVC collapsibility index can be used as a non-invasive indicator of intravascular volume status and hemodynamic changes during lumbar spine surgery.
Detailed description
his prospective study aims to evaluate perioperative hemodynamic changes using the inferior vena cava (IVC) collapsibility index in patients undergoing lumbar stabilization surgery under general anesthesia in the prone position. The inferior vena cava diameter will be measured using ultrasonography at different perioperative time points, including the preoperative period, after induction of anesthesia, and before extubation.
The IVC diameter and collapsibility index will be recorded and analyzed to assess changes in intravascular volume status during the perioperative period. In addition to ultrasonographic measurements, hemodynamic parameters such as blood pressure and heart rate will be monitored and recorded.
The study aims to investigate whether the IVC collapsibility index can be used as a non-invasive indicator of intravascular volume status and perioperative hemodynamic changes in patients undergoing lumbar spine surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing Lumbar Spine Surgery | – | –Adult patients undergoing elective lumbar spine stabilization surgery under general anesthesia in the prone position. Inferior vena cava (IVC) diameter and collapsibility index will be measured using ultrasonography at predefined perioperative time points (preoperative period, after induction of anesthesia, and before extubation). Hemodynamic parameters such as blood pressure and heart rate will also be recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) scheduled for elective lumbar spine stabilization surgery under general anesthesia at Trabzon University Faculty of Medicine Hospital will be included in this study. All participants will be classified as ASA physical status I-II-III and will undergo surgery in the prone position. Inferior vena cava (IVC) diameter and collapsibility index will be measured using ultrasonography at predefined perioperative time points.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Patients classified as ASA physical status I-II-III
- Patients scheduled for elective lumbar spine stabilization surgery under general anesthesia
- Ability to obtain adequate inferior vena cava (IVC) ultrasonographic imaging
- Provision of written informed consent
Key exclusion criteria (13 listed)
- Age younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inferior Vena Cava Collapsibility Index
Time frame: Perioperative period (preoperative assessment, after anesthesia induction, and before extubation)
The inferior vena cava (IVC) collapsibility index will be measured using ultrasonography at predefined perioperative time points (preoperative period, after induction of general anesthesia, and before extubation) in patients undergoing elective lumbar spine surgery in the prone position.
1 secondary outcome
Intraoperative Hypotension Incidence
Time frame: During the intraoperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Background: PubMed 30475290Yoon HK, Lee HC, Chung J, Park HP. Predictive Factors for Hypotension Associated With Supine-to-Prone Positional Change in Patients Undergoing Spine Surgery. J Neurosurg Anesthesiol. 2020 Apr;32(2):140-146. doi: 10.1097/ANA.0000000000000565.
- Background: PubMed 38794845Lee S, Kim DY, Han J, Kim K, You AH, Kang HY, Park SW, Kim MK, Kim JE, Choi JH. Hemodynamic changes in the prone position according to fluid loading after anaesthesia induction in patients undergoing lumbar spine surgery: a randomized, assessor-blind, prospective study. Ann Med. 2024 Dec;56(1):2356645. doi: 10.1080/07853890.2024.2356645. Epub 2024 May 24.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the dataset contains patient-level clinical information collected during routine clinical care. Data may be available from the investigators upon reasonable request and with approval from the institutional ethics committee.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spine Surgery and Hemodynamic Changes, run by Trabzon Kanuni Education and Research Hospital at 2 sites 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Şeyma Yüksel Ayar, MD (+905395655853, balseymayuksel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inferior Vena Cava Collapsibility Index (time frame: Perioperative period (preoperative assessment, after anesthesia induction, and before extubation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07549165, which also lists 2 linked publications.
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 23 Apr 2026.