NCT06767033

Brief Summary

The aim of this study was to evaluate the role of inferior vena cava collapsibility index assessment in predicting post spinal anaesthesia hypotension in patients undergoing arthroscopic knee surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 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

Study Start

First participant enrolled

February 22, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
Last Updated

January 9, 2025

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

January 5, 2025

Last Update Submit

January 5, 2025

Conditions

Keywords

Inferior Vena Cava Collapsibility IndexPost Spinal Anaesthesia HypotensionArthroscopic Knee Surgeries

Outcome Measures

Primary Outcomes (1)

  • to determine the optimal cut-off value of ultrasound guided IVCCI to predict post spinal anaesthesia hypotension.

    6 months

Secondary Outcomes (1)

  • to measure the total amount of fluids and vasopressor drugs administered to patients to manage post spinal anaesthesia hypotension

    6 months

Interventions

Before spinal anaesthesia, inferior vena cava collapsibility index was measured for all patients using Ultrasound device.

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients American Society of Anesthesiologists Physical Status (ASA) I to II undergoing arthroscopic knee surgeries under spinal anaesthesia.

You may qualify if:

  • Patients: American Society of Anesthesiologists Physical Status (ASA) I to II undergoing arthroscopic knee surgeries under spinal anaesthesia.
  • Both Sexes.
  • Aged 30 to 60 years.
  • Body mass index \<35 kg/m2

You may not qualify if:

  • Patients' refusal of procedure or participation in the study.
  • Patients with contraindication to spinal anaesthesia.
  • Patients with severe cardiovascular or pulmonary disease.
  • Patients with pre-procedural hypotension (systolic arterial pressure less than 90 mmHg and/or mean arterial pressure less than 60 mmHg).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2025

First Posted

January 9, 2025

Study Start

February 22, 2024

Primary Completion

August 22, 2024

Study Completion

September 1, 2024

Last Updated

January 9, 2025

Record last verified: 2024-09

Locations