NCT06479512

Brief Summary

The aim of our study was to predict hypotension by using caval aorta index and perfusion index in elderly patients who may develop hypotension after spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

June 24, 2024

Last Update Submit

December 19, 2025

Conditions

Keywords

spinal anesthesiacaval aorta indexperfusion indexorthopedic surgeryelderly patients

Outcome Measures

Primary Outcomes (1)

  • caval aorta index for predicting hypotension in the elderly

    to determine the threshold value for the caval aorta index in determining hypotension using logistic regression analysis

    1 hour

Secondary Outcomes (12)

  • perfusion index for predicting hypotension in the elderly

    1 hour

  • inferior vena cava diameter for predicting hypotension in the elderly

    1 hour

  • abdominal aort diameter for predicting hypotension in the elderly

    1 hour

  • systolic blood pressure

    1 hour

  • diastolic blood pressure

    1 hour

  • +7 more secondary outcomes

Study Arms (2)

patients with spinal induced hypotension

patients with hypotension after spinal anesthesia (SBP less than 90 mmHg, a decrease in SBP by more than 30% from the preoperative baseline value, or an MAP below 60 mmHg)

Device: ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion index

patients without spinal induced hypotension

patients without spinal induced hypotension

Device: ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion index

Interventions

Inferior vena cava and aortic diameter measurements will be made by ultrasonography and perfusion index determination using non-invasive pulse oximetry

patients with spinal induced hypotensionpatients without spinal induced hypotension

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients over 60 years of age who will undergo elective lower extremity surgery in supine position admitted to ankara city hospital

You may qualify if:

  • American Society of Anesthesiology(ASA) I-II-III score
  • Patients over 60 years
  • Elective surgeries
  • Surgeries in supine position

You may not qualify if:

  • Patient refusal to participate in the study
  • The patient will undergo emergency surgery
  • Contraindication to spinal anaesthesia
  • Planning unilateral spinal anaesthesia
  • Failure of spinal anaesthesia
  • Body mass index above 35kg/m2
  • Presence of preoperative hypotension (SBP\<90mmHg or MAP\<60mmHg)
  • The patient has valvular disease and arrhythmia impairing haemodynamics
  • Presence of neuropsychiatric disorders that make communication difficult
  • Presence of abdominal hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, Turkey, 06800, 06800, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Perfusion Index

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiology and reanimation associate professor

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 28, 2024

Study Start

July 1, 2024

Primary Completion

April 15, 2025

Study Completion

May 25, 2025

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations