NCT07549165

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Feb 2026Jul 2026

Study Start

First participant enrolled

February 15, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Expected
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

April 17, 2026

Last Update Submit

April 17, 2026

Conditions

Keywords

Inferior Vena Cava • IVC Collapsibility Index • Lumbar Stabilization Surgery • Hemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

  • 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.

    Perioperative period (preoperative assessment, after anesthesia induction, and before extubation)

Secondary Outcomes (1)

  • Intraoperative Hypotension Incidence

    During the intraoperative period

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Trabzon University Faculty of Medicine Kanunı Training and Research Hospital ,Trabzon

Trabzon, 61080, Turkey (Türkiye)

RECRUITING

Trabzon University Faculty of Medicine, Kanuni Training and Research Hospital

Trabzon, 61080, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 30475290BACKGROUND
  • 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.

    PMID: 38794845BACKGROUND

Central Study Contacts

Şeyma Yüksel Ayar, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Araştırma Görevlisi

Study Record Dates

First Submitted

April 17, 2026

First Posted

April 23, 2026

Study Start

February 15, 2026

Primary Completion

February 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations