NCT06530901

Brief Summary

Based on the preoperative ultrasound detection of various parametric indicators of the inferior vena cava cross-section, including the ratio of the inferior vena cava's long and short axes, cross-sectional area and circumference during two-dimensional and three-dimensional imaging, as well as the changes in respiratory variability of each parameter, we explored the predictive value of IVC ultrasound indicator parameters on hypotension after induction of general anesthesia in elderly patients undergoing elective non-cardiac surgery, screened the sensitive indicators, and calculated the cut-off values.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

August 5, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

July 28, 2024

Last Update Submit

August 1, 2024

Conditions

Keywords

hypotensiongeneral anesthesiainferior vena cava

Outcome Measures

Primary Outcomes (3)

  • Changes in the level of Mean Arterial Pressure

    The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction

    Baseline (before induction), 10 min after induction

  • Changes in the level of Systolic Blood Pressure

    The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction

    Baseline (before induction), 10 min after induction

  • Multidimensional ultrasound of the inferior vena cava

    The outcome above should be measured at the time before induction

    Baseline (before induction)

Secondary Outcomes (2)

  • Changes in the level of Heart Rate

    Baseline (before induction), 10 min after induction

  • Changes in the level of Diastolic Blood Pressure

    Baseline (before induction), 10 min after induction

Study Arms (1)

Elderly patients undergoing elective noncardiac surgery under general anesthesia

Diagnostic Test: Multidimensional ultrasound of the inferior vena cava

Interventions

Cross-sectional parameters of the inferior vena cava include two-dimensional longitudinal diameter, cross-sectional length and short diameter, circumference, and cross-sectional area, as well as cross-sectional length and short diameter, circumference, and cross-sectional area in three-dimensional imaging

Elderly patients undergoing elective noncardiac surgery under general anesthesia

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly patients undergoing elective non-cardiac surgery under general anesthesia

You may qualify if:

  • Elderly patients undergoing elective non-cardiac surgery under general anesthesia;
  • Age 65-85 years old;
  • Body mass index (BMI) 18-28 kg/m2;
  • American society of anesthesiologists (ASA) class I-III.

You may not qualify if:

  • Patient refusal or lack of cooperation;
  • Inability to communicate properly;
  • Severe sinus bradycardia, pacemaker implantation, atrioventricular block, and atrial fibrillation;
  • Presence of severe hepatic and renal function abnormalities;
  • Preoperative cardiac ultrasound suggesting LVEF \<50%;
  • Tricuspid valve displacement \<16 mm by preoperative cardiac ultrasound;
  • Chronic obstructive pulmonary disease;
  • Pulmonary hypertension;
  • Administration of drugs that inhibit the renin-angiotensin-aldosterone system;
  • Possibility of a difficult airway.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • zhuan zhang, professor

    The Affiliated Hospital of Yangzhou University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

zhuan zhang, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 28, 2024

First Posted

July 31, 2024

Study Start

September 1, 2024

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

August 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations