Preoperative Ultrasonographic Evaluation of Caval Aorta Diameter Index

November 30, 2023 updated by: Egymedicalpedia

Preoperative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a New Predictor for Hypotension After Induction of General Anesthesia in Geriatric Patients

General anesthesia is frequently used in daily clinical practice. Elderly patients often require a higher level of care than younger patients during the perioperative period, with higher health care costs.

Strategies to optimize anesthesia care to reduce complications and improve outcomes in elderly surgical patients will also be of great value to the individual patients and society.

Study Overview

Detailed Description

Prevention of an undesired hypotensive event has a key role in providing patient safety. Patients' susceptibility to intra-operative hypotension can be influenced by the pre-operative volume status.

Despite worldwide improvement in preoperative optimization and changing practices, promoting the avoidance of unnecessary fasting and mechanical bowel preparation, optimized fluid therapy remains the cornerstone of treatment with excellent effectiveness.

The earlier, non-invasive and bedside investigation for assessment of volume status will enhance the effective prevention and management of post-induction hypotension and hence better clinical outcome .

Several methodologies have been tried with a specific goal to predict post-induction hypotension, including heart rate variability (HRV), passive leg raise test and perfusion index.

Despite this, assessing intravascular volume status is still challenging matter. Therefore, the aim of this study will be to compare between the collapsibility index of the inferior vena cava (IVCCI) and IVC to aorta diameter index (IVCD: AoD index) as a potential screening tool to identify patients who are vulnerable to hypotensive events related to general anesthesia.

IVCCI has been tested before in several studies as a predictor of post-induction hypotension. However, IVCD: AoD index has not been investigated before for prediction of hypotension after induction of general anesthesia in elderly. Among the earliest studies to assess the IVCD: AoD index was carried out by Kodiak et al., in hypovolemic patients.

Additionally, it has been investigated for predicting the postspinal anesthesia hypotension and showed promising results

Study Type

Observational

Enrollment (Estimated)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Cairo, Egypt
        • Recruiting
        • Al-Azhar University Hospitals
        • Contact:
        • Principal Investigator:
          • Ahmed Sedeek, Lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing elective surgery under general anesthesia, ASA I, II

Description

Inclusion Criteria:

  • Adult patients ( 60 - 85 ) years old of both sexes with American Society of Anesthesiologists (ASA) physical status I-II and scheduled for elective surgeries under general anesthesia.

Exclusion Criteria:

  1. Refusal to join the study.
  2. Mental and psychiatric disorders (un co-operative patients).
  3. Emergency operations
  4. ASA physical status > II
  5. Dyspnea, respiratory distress, un-compensated respiratory disease (generalized wheezes, defective functional capacity, peripheral O2 saturation less than 90% on room air )
  6. patients with uncontrolled hypertension, Systolic blood pressure ≥ 180 mmHg
  7. IVC non visualized
  8. Patients with increased intra-abdominal pressure (intra-abdominal mass compressing IVC).
  9. anticipated or accidental discovered difficult airway
  10. patients taking angiotensin converting enzyme inhibitors or angiotensin receptors blockers, documented heart failure, elevated pulmonary arterial pressure > 40 mmHg, significant valvular heart disease, significant carotid stenosis, peripheral vascular diseases, unstable angina or cardiac ejection fraction less than 40%, implanted pacemaker or cardioversion , known cases of abdominal aortic abnormality as aneurysm or previous operations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the predictive value of pre-induction IVC
Time Frame: 5 minutes
Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of post-induction hypotension
Time Frame: 5 minutes
Correlation between each of maximum aortic diameter with the percentage of the maximum decrease in mean arterial pressure after induction of anesthesia
5 minutes
Correlation between each of IVC collapsibility index with the percentage of the maximum decrease in mean arterial pressure after induction of anesthesia
Time Frame: 5 minutes
Correlation between each of IVC collapsibility index with the percentage of themaximum decrease in mean arterial pressure after induction of anesthesia
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Ahmed Saied, Professor, Al-Azhar University, Faculty of medicine for boys

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

November 19, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 4, 2023

Study Record Updates

Last Update Posted (Actual)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anaesth._0319/2023Med.Research

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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