Pre-operative Ultrasonographic Evaluation of Caval Aorta... | NCT04658576

Studies
Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a Predictor for Post-induction Hypotension

NCT04658576

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jul 5, 2023Actual

Enrollment

96Actual

Phase

Not provided

Conditions

Hypotension on Induction

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

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

Dec 1, 2020Actual

Primary Completion Date

Oct 23, 2022Actual

Completion Date

Oct 23, 2022Actual

First Submitted Date

Dec 2, 2020

First Submission Date that Met QC Criteria

Dec 2, 2020

First Posted Date

Dec 8, 2020Actual

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

Jul 2, 2023

Last Update Posted Date

Jul 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparison between ultrasound measurement of IVCD-AOd index in prediction of post induction hypo tension

Detailed Description

This study aims to evaluate the ability of preoperative ultrasound measurements IVC to aorta diameter index to predict post-induction hypotension in comparison with ultrasound measurements of the IVC collapsibility index.

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

96Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
• Comparison of the accuracy Area under receiver operating characteristic curves (AUROC) of IVCD:AoD index and IVCCI in prediction of post-induction hypotension	Measurement of pre-operative IVC-AOrta diameter index and IVC collapsibility index	15 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Adult patients (>18years)
- ASA I-II

Exclusion Criteria:

• ASA physical status > II
- Dyspnea
- Systolic blood pressure ≥ 180 mmHg
- Systolic blood pressure < 90 mmHg
- Agitation (RASS > 1)
- IVC non visualized
- Epidural catheter in use
- Patients with increased intraabdominal pressure (intrabdominal mass compressing IVC).
- Pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

• Patients scheduled for elective orthopedic surgeries under general anaesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shymaa Fathy, MD	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine- Cairo University		Cairo		11562	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided