NCT04658576

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

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

December 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2022

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

December 2, 2020

Last Update Submit

July 2, 2023

Conditions

Hypotension on Induction

Outcome Measures

Primary Outcomes (1)

  • • 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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

• Patients scheduled for elective orthopedic surgeries under general anaesthesia

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine- Cairo University

Cairo, 11562, Egypt

Location

Study Officials

  • Shymaa Fathy, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and SICU

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 8, 2020

Study Start

December 1, 2020

Primary Completion

October 23, 2022

Study Completion

October 23, 2022

Last Updated

July 5, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)