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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02944266
• Other study ID #: NK/2172/MD/11249-50
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2016
• Last updated: October 23, 2016
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Rahul JS Dr, MD
• Phone: 8437722798
• Email: drrahulsamj[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypotension
• Hypovolemia
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Other:
• Pre operative Focus assessed Transthoracic echocardiographic assessment.

Locations

Country	Name	City	State
India	J S Rahul	Chandigarh

Sponsors (2)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research	Postgraduate Institute of Medical Education and Research, Chandigarh

Country where clinical trial is conducted

India, 

References & Publications (21)

Alecu C, Cuignet-Royer E, Mertes PM, Salvi P, Vespignani H, Lambert M, Bouaziz H, Benetos A. Pre-existing arterial stiffness can predict hypotension during induction of anaesthesia in the elderly. Br J Anaesth. 2010 Nov;105(5):583-8. doi: 10.1093/bja/aeq231. Epub 2010 Aug 26. — View Citation

American Society of Anesthesiologists and Society of Cardiovascular Anesthesiologists Task Force on Transesophageal Echocardiography.. Practice guidelines for perioperative transesophageal echocardiography. An updated report by the American Society of Anesthesiologists and the Society of Cardiovascular Anesthesiologists Task Force on Transesophageal Echocardiography. Anesthesiology. 2010 May;112(5):1084-96. doi: 10.1097/ALN.0b013e3181c51e90. — View Citation

Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930. — View Citation

Brienza N, Giglio MT, Marucci M, Fiore T. Does perioperative hemodynamic optimization protect renal function in surgical patients? A meta-analytic study. Crit Care Med. 2009 Jun;37(6):2079-90. doi: 10.1097/CCM.0b013e3181a00a43. Review. — View Citation

Colreavy FB, Donovan K, Lee KY, Weekes J. Transesophageal echocardiography in critically ill patients. Crit Care Med. 2002 May;30(5):989-96. — View Citation

Cowie B. Focused cardiovascular ultrasound performed by anesthesiologists in the perioperative period: feasible and alters patient management. J Cardiothorac Vasc Anesth. 2009 Aug;23(4):450-6. doi: 10.1053/j.jvca.2009.01.018. — View Citation

David M C, Vicki N E Assessing volume status and fluid responsiveness in the emergency department Clin Exp Emerg Med 2014;1(2):67-77

Devereaux PJ, Goldman L, Cook DJ, Gilbert K, Leslie K, Guyatt GH. Perioperative cardiac events in patients undergoing noncardiac surgery: a review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk. CMAJ. 2005 Sep 13;173(6):627-34. Review. — View Citation

Feissel M, Michard F, Faller JP, Teboul JL. The respiratory variation in inferior vena cava diameter as a guide to fluid therapy. Intensive Care Med. 2004 Sep;30(9):1834-7. Epub 2004 Mar 25. — View Citation

Feissel M, Michard F, Mangin I, Ruyer O, Faller JP, Teboul JL. Respiratory changes in aortic blood velocity as an indicator of fluid responsiveness in ventilated patients with septic shock. Chest. 2001 Mar;119(3):867-73. — View Citation

Filipovic M, Seeberger MD, Schneider MC, Schmid M, Pargger H, Hunziker P, Skarvan K. Transthoracic echocardiography for perioperative haemodynamic monitoring. Br J Anaesth. 2000 Jun;84(6):800-3. — View Citation

Gauss A, Heinrich H, Wilder-Smith OH. Echocardiographic assessment of the haemodynamic effects of propofol: a comparison with etomidate and thiopentone. Anaesthesia. 1991 Feb;46(2):99-105. — View Citation

Jensen MB, Sloth E, Larsen KM, Schmidt MB. Transthoracic echocardiography for cardiopulmonary monitoring in intensive care. Eur J Anaesthesiol. 2004 Sep;21(9):700-7. — View Citation

Lienhart A, Auroy Y, Péquignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. — View Citation

Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. Review. — View Citation

Michard F. Changes in arterial pressure during mechanical ventilation. Anesthesiology. 2005 Aug;103(2):419-28; quiz 449-5. Review. — View Citation

Mulier JP, Wouters PF, Van Aken H, Vermaut G, Vandermeersch E. Cardiodynamic effects of propofol in comparison with thiopental: assessment with a transesophageal echocardiographic approach. Anesth Analg. 1991 Jan;72(1):28-35. — View Citation

Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-8, table of contents. — View Citation

Reuter DA, Felbinger TW, Schmidt C, Kilger E, Goedje O, Lamm P, Goetz AE. Stroke volume variations for assessment of cardiac responsiveness to volume loading in mechanically ventilated patients after cardiac surgery. Intensive Care Med. 2002 Apr;28(4):392-8. — View Citation

Shillcutt SK, Markin NW, Montzingo CR, Brakke TR. Use of rapid "rescue" perioperative echocardiography to improve outcomes after hemodynamic instability in noncardiac surgical patients. J Cardiothorac Vasc Anesth. 2012 Jun;26(3):362-70. doi: 10.1053/j.jvca.2011.09.029. — View Citation

Tsuchiya M, Yamada T, Asada A. Pleth variability index predicts hypotension during anesthesia induction. Acta Anaesthesiol Scand. 2010 May;54(5):596-602. doi: 10.1111/j.1399-6576.2010.02225.x. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension	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	No