- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02944266
Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Rahul JS Dr, MD
- Telefonnummer: 8437722798
- E-mail: drrahulsamj@gmail.com
Undersøgelse Kontakt Backup
- Navn: Dr vikas saini, MD
- Telefonnummer: +91 7087008119
- E-mail: drvsaini@gmail.com
Studiesteder
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Chandigarh, Indien, 160012
- Rekruttering
- J S Rahul
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Kontakt:
- Dr vikas saini, MD
- Telefonnummer: 7087008119
- E-mail: drvsaini@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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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 .
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Normovolaemia group
Those patients without the above said TTE findings are hypothesised to be normovolaemic and grouped in here.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension
Tidsramme: January 2016- November 2016
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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
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January 2016- November 2016
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NK/2172/MD/11249-50
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