NCT05239234

Brief Summary

The purpose of the study is to evaluate the predictive value of the inferior vena cava collapsibility index and caval aorta index for detecting hypotension after induction of general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

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

First Submitted

Initial submission to the registry

January 19, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

March 2, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2022

Completed
Last Updated

November 28, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

January 19, 2022

Last Update Submit

November 24, 2022

Conditions

General AnesthesiaHypotension on Induction

Outcome Measures

Primary Outcomes (2)

  • Diagnostic value of IVCCI to detect post-induction hypotension assessed by Receiver operating characteristic (ROC) curve analysis.

    Measurement of inferior vena cava collapsibility index.

    20 minutes

  • Diagnostic value of IVC : Ao index to detect post-induction hypotension assessed by ROC curve analysis.

    Measurement of inferior vena cava-Aorta diameter index.

    20 minutes

Interventions

Inferior vena cava-Aorta diameter indexOTHER

Before the induction of general anesthesia, inferior vena cava-Aorta diameter index and inferior vena cava collapsibility index will be measured.

Also known as: Inferior vena cava collapsibility index

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who scheduled for elective non-cardiac surgery under general anesthesia

You may qualify if:

  • patients more than 18 years of age
  • American Society of Anesthesiologists' (ASA) physical status 1 or 2

You may not qualify if:

  • BMI more than 30 kg/m²
  • Use of angiotensin converting enzyme inhibitors
  • pregnancy,
  • emergency operations
  • baseline arterial systolic blood pressure less than 90 mmHg
  • mean arterial blood pressure less than 70 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Researching Hospital

Antalya, Turkey (Türkiye)

Location

Study Officials

  • Enes Eskin, M.D.

    Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 19, 2022

First Posted

February 14, 2022

Study Start

March 2, 2022

Primary Completion

November 9, 2022

Study Completion

November 12, 2022

Last Updated

November 28, 2022

Record last verified: 2022-01

Locations

TU(1)