NCT07399093

Brief Summary

This study aims to assess the accuracy, repeatability, and reproducibility of preoperative evaluation of Inferior Vena Cava (IVC) collapsibility index and caval aorta index for prediction of hypotension after induction of general anesthesia.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

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 Start

First participant enrolled

January 14, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

July 24, 2025

Last Update Submit

February 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of ultrasound guided Aorto-Caval index (IVC-AO)

    Sensitivity of ultrasound guided Aorto-Caval index (IVC-AO) to predict hypotension will be recorded.

    15 minutes post-induction of general anesthesia.

Secondary Outcomes (3)

  • Specificity of ultrasound guided Aorto-Caval index (IVC-AO)

    15 minutes post-induction of general anesthesia.

  • Sensitivity of inferior vena cava (IVC) collapsibility index

    15 minutes post-induction of general anesthesia.

  • Specificity of inferior vena cava (IVC) collapsibility index

    15 minutes post-induction of general anesthesia.

Study Arms (1)

Study group

Patients scheduled for elective craniotomy surgeries before induction of general anesthesia.

Other: Inferior vena cava collapsibility indexOther: Caval Aorta Index

Interventions

Inferior vena cava (IVC) collapsibility index (IVCCI) will be measured. The IVCCI is calculated using the following formula: IVCCI = (maximum IVC diameter - minimum IVC diameter) / maximum IVC diameter \* 100

Study group

The Inferior vena cava (IVC): Ao index will be derived by taking the ratio of the maximum IVC diameter during expiration and the maximal abdominal aortic diameter during systole. \- The caval aorta index (IVC/Ao) is calculated using the following formula: IVC/Ao index = IVC diameter / aortic diameter.

Study group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This prospective cohort study will be conducted on 40 patients undergoing craniotomy surgeries at Ain Shams University Hospitals.

You may qualify if:

  • Age from 18 to 40 years.
  • Both sexes.
  • Body Mass Index\< 40 kg/m².
  • American Society of Anesthesiologists (ASA) physical status I, II.
  • Fasted according to the ASA guidelines: 2 hours for clear fluids, 6 hours after light meal, 8 hours after a full meal with high calorie or fat content.
  • Scheduled for elective craniotomy surgeries before induction of general anesthesia.

You may not qualify if:

  • Current or recent pregnancy (within 3 months).
  • Pre-existing cardiac disease or hypertension.
  • On medications affecting blood pressure \[Beta-blockers (BBs) and calcium channel blockers (CCBs)\] .
  • Refusing to undergo the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11591, Egypt

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Anesthesia, Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt

Study Record Dates

First Submitted

July 24, 2025

First Posted

February 10, 2026

Study Start

January 14, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations