- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07549165
IVC Collapsibility Index in Lumbar Stabilization Surgery
Hemodynamic Assessment Using the Inferior Vena Cava Collapsibility Index in Patients Undergoing Lumbar Stabilization Surgery
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Şeyma Yüksel Ayar, MD
- Phone Number: +905395655853
- Email: balseymayuksel@hotmail.com
Study Locations
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Trabzon, Turkey (Türkiye), 61080
- Recruiting
- Trabzon University Faculty of Medicine Kanunı Training and Research Hospital ,Trabzon
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Trabzon, Turkey (Türkiye), 61080
- Recruiting
- Trabzon University Faculty of Medicine, Kanuni Training and Research Hospital
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Contact:
- Recep Erin, MD
- Phone Number: +905304699135
- Email: erinrecep@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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%
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Inferior Vena Cava Collapsibility Index
Time Frame: Perioperative period (preoperative assessment, after anesthesia induction, and before extubation)
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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.
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Perioperative period (preoperative assessment, after anesthesia induction, and before extubation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Intraoperative Hypotension Incidence
Time Frame: During the intraoperative period
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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.
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During the intraoperative period
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Collaborators and Investigators
Publications and helpful links
General Publications
- Lee 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 10496660-2026/25031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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