Inferior Vena Cava Collapsibility Index Assessment in Pre... | NCT06767033

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2024Actual

Primary Completion Date

Aug 22, 2024Actual

Completion Date

Sep 1, 2024Actual

First Submitted Date

Jan 5, 2025

First Submission Date that Met QC Criteria

Jan 5, 2025

First Posted Date

Jan 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2025

Last Update Posted Date

Jan 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Prospective Cohort Study conducted in Ain Shams University Hospitals.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound Guided Inferior Vena Cava Collapsibility Index Assessment	Device	Before spinal anaesthesia, inferior vena cava collapsibility index was measured for all patients using Ultrasound device.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to determine the optimal cut-off value of ultrasound guided IVCCI to predict post spinal anaesthesia hypotension.		6 months

Secondary Outcomes

Measure	Description	Time Frame
to measure the total amount of fluids and vasopressor drugs administered to patients to manage post spinal anaesthesia hypotension		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University Hospitals		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.