Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension

October 23, 2016 updated by: J S Rahul, Postgraduate Institute of Medical Education and Research
This is an observational study to evaluate the role of a Bed side Focus assessed Transthoracic Echocardiography (FATE) in identifying the patients at a potential risk of developing hypotension secondary to general anesthesia induction using the FATE parameters like velocity time integral ( VTI ), Inferior venacava diameter , Caval index and Left ventricular end end diastolic area.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Various haemodynamic parameters like central venous pressure , pulmonary capillary wedge pressure , systolic pulse pressure variations , stroke volume variation , pleth variability index etc are being used as markers of volume status and which in turn have been used as indicators of post general anesthesia induction hypotension in the past . In the current study the investigators aim to validate the role of a bed side 2-D transthoracic echocardiography (TTE) as a guide to identify the volume status of the patient before induction and clinically observe for the haemodynamic changes in the form of mean arterial pressure variations in the immediate post induction period.

The investigators aim to perform preoperative bed side Transthoracic echocardiography in 150 American society of Anesthesiologists grade-I/II patients posted for routine General anaesthesia procedures and assess their volume status . Then the investigators would collect 10 mean arterial pressure recordings at one minute interval in the immediate postinduction period and assess the accuracy of TTE in identifying potential patients at risk of developing post induction hypotension.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

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

Study Locations

  • India
      • Chandigarh, India, 160012
        • Recruiting
        • J S Rahul
        • Contact:

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Any ASA - I/II patient posted for a routine general anaesthesia procedure who is between the age groups 18-60 years, with a BMI between 18-40 , without preexisting haemodynamic instability , sepsis or a documented ventricular dysfunction.

Description

Inclusion Criteria:

  • Any ASA - I/II patient posted for a routine general anaesthesia procedure and who do not fit with the exclusion criteria.

Exclusion Criteria:

  • a) Extremes of age <18 years and >60 years

    b) BMI<18 and >40

    c) Patients with pre-existing hemodynamic instability, ventricular dysfunction and

Sepsis.

d) Patients on beta blocking agents.

e) Preinduction mean arterial pressure of <70 mm hg.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypovolemia group
Those patients who are said to be positive for one or more of the following TTE criteria are grouped under this , them being i.IVC diameter of less than 1 cm , ii.Caval index of > 50%, iii.Left ventricular end diastolic area of < 10 cm2 iv. VTI variation with respiration of < 12.5%, are grouped under the hypovolaemia group .
Other: Pre operative Focus assessed Transthoracic echocardiographic assessment.
Normovolaemia group
Those patients without the above said TTE findings are hypothesised to be normovolaemic and grouped in here.
Other: Pre operative Focus assessed Transthoracic echocardiographic assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension
Time Frame: January 2016- November 2016
Role of Transthoracic echocardiography in assessing preoperative volume status using various parameters like Velocity time integral , Inferior vena cava diameter , Caval index , Left Ventricular end diastolic area etc ., in accurately predicting the incidence of hypotension at the time of induction in patients who are being administered general anaesthesia
January 2016- November 2016

Collaborators and Investigators

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

Sponsor

Postgraduate Institute of Medical Education and Research

Collaborators

Postgraduate Institute of Medical Education and Research, Chandigarh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 23, 2016

First Posted (Estimate)

October 25, 2016

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 23, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK/2172/MD/11249-50

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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