Clinical trial NCT02944266: Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension
Official title: Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypotension
Keywords: post general anaesthesia induced
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2016-10-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension
timeFrame: January 2016- November 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: J S Rahul
Study officials:
References:
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