Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
Study NCT ID:
NCT02944266
Status:
UNKNOWN
Last Update Posted:
2016-10-25
First Post:
2016-10-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-23', 'studyFirstSubmitDate': '2016-10-13', 'studyFirstSubmitQcDate': '2016-10-23', 'lastUpdatePostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension', 'timeFrame': 'January 2016- November 2016', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['post general anaesthesia induced'], 'conditions': ['Hypotension']}, 'referencesModule': {'references': [{'pmid': '16115962', 'type': 'BACKGROUND', '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):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.'}, {'pmid': '17122571', 'type': 'BACKGROUND', 'citation': 'Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.'}, {'pmid': '16157727', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1503/cmaj.050011.'}, {'pmid': '19934864', 'type': 'BACKGROUND', '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.'}, {'pmid': '12065368', 'type': 'BACKGROUND', 'citation': 'Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.'}, {'pmid': '16052125', 'type': 'BACKGROUND', 'citation': 'Michard F. Changes in arterial pressure during mechanical ventilation. Anesthesiology. 2005 Aug;103(2):419-28; quiz 449-5. doi: 10.1097/00000542-200508000-00026.'}, {'pmid': '15045170', 'type': 'BACKGROUND', '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. doi: 10.1007/s00134-004-2233-5. Epub 2004 Mar 25.'}, {'pmid': '11967591', 'type': 'BACKGROUND', '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. doi: 10.1007/s00134-002-1211-z. Epub 2002 Mar 20.'}, {'pmid': '11243970', 'type': 'BACKGROUND', '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. doi: 10.1378/chest.119.3.867.'}, {'pmid': '10895760', 'type': 'BACKGROUND', '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. doi: 10.1093/oxfordjournals.bja.a013596.'}, {'pmid': '15595582', 'type': 'BACKGROUND', '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. doi: 10.1017/s0265021504009068.'}, {'pmid': '19303330', 'type': 'BACKGROUND', '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. Epub 2009 Mar 19.'}, {'pmid': '20418689', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '12006793', 'type': 'BACKGROUND', 'citation': 'Colreavy FB, Donovan K, Lee KY, Weekes J. Transesophageal echocardiography in critically ill patients. Crit Care Med. 2002 May;30(5):989-96. doi: 10.1097/00003246-200205000-00007.'}, {'pmid': '19384211', 'type': 'BACKGROUND', '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.'}, {'pmid': '20798172', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20236098', 'type': 'BACKGROUND', '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. Epub 2010 Mar 10.'}, {'pmid': '22226417', 'type': 'BACKGROUND', '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. Epub 2012 Jan 4.'}, {'pmid': '1872460', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1365-2044.1991.tb09349.x.'}, {'pmid': '1984373', 'type': 'BACKGROUND', '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. doi: 10.1213/00000539-199101000-00006.'}, {'pmid': '27752556', 'type': 'BACKGROUND', 'citation': 'Mackenzie DC, Noble VE. Assessing volume status and fluid responsiveness in the emergency department. Clin Exp Emerg Med. 2014 Dec 31;1(2):67-77. doi: 10.15441/ceem.14.040. eCollection 2014 Dec.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any ASA - I/II patient posted for a routine general anaesthesia procedure and who do not fit with the exclusion criteria.\n\nExclusion Criteria:\n\n* a) Extremes of age \\<18 years and \\>60 years\n\n b) BMI\\<18 and \\>40\n\n c) Patients with pre-existing hemodynamic instability, ventricular dysfunction and\n\nSepsis.\n\nd) Patients on beta blocking agents.\n\ne) Preinduction mean arterial pressure of \\<70 mm hg.'}, 'identificationModule': {'nctId': 'NCT02944266', 'briefTitle': 'Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, 'officialTitle': 'Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension', 'orgStudyIdInfo': {'id': 'NK/2172/MD/11249-50'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypovolemia group', 'description': '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 .', 'interventionNames': ['Other: Pre operative Focus assessed Transthoracic echocardiographic assessment.']}, {'label': 'Normovolaemia group', 'description': 'Those patients without the above said TTE findings are hypothesised to be normovolaemic and grouped in here.', 'interventionNames': ['Other: Pre operative Focus assessed Transthoracic echocardiographic assessment.']}], 'interventions': [{'name': 'Pre operative Focus assessed Transthoracic echocardiographic assessment.', 'type': 'OTHER', 'armGroupLabels': ['Hypovolemia group', 'Normovolaemia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Chandigarh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr vikas saini, MD', 'role': 'CONTACT', 'email': 'drvsaini@gmail.com', 'phone': '7087008119'}], 'facility': 'J S Rahul', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'centralContacts': [{'name': 'Rahul JS Dr, MD', 'role': 'CONTACT', 'email': 'drrahulsamj@gmail.com', 'phone': '8437722798'}, {'name': 'Dr vikas saini, MD', 'role': 'CONTACT', 'email': 'drvsaini@gmail.com', 'phone': '+91 7087008119'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Junior resident , Department of Anaesthesia and Intensive care', 'investigatorFullName': 'J S Rahul', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}