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

• Conditions: Hypotension
• Interventions: Other: Pre operative Focus assessed Transthoracic echocardiographic assessment.

• Registration Number: NCT02944266
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

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.

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 Timeline

• Study Start: 2016-01
• Status Verified: 2016-10
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-23
• Last Update Submitted: 2016-10-23
• Study First Posted: 2016-10-25
• Last Update Posted: 2016-10-25
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypovolemia group	Pre operative Focus assessed Transthoracic echocardiographic assessment.	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 .
Normovolaemia group	Pre operative Focus assessed Transthoracic echocardiographic assessment.	Those patients without the above said TTE findings are hypothesised to be normovolaemic and grouped in here.

Primary Outcome Measures

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

Trial Locations

Locations (1)

J S Rahul; 🇮🇳 Chandigarh, India