Study Results
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View full resultsBasic Information
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COMPLETED
NA
429 participants
INTERVENTIONAL
2014-05-31
2019-08-31
Brief Summary
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The most feared and common of its well known side effects consist in an abrupt reduction of systemic vascular resistances, with consequence risk of systemic hypotension. To prevent this potentially severe complication, an adequate correction of patients' volume status through a preventive administration of fluids is widely used.
However this volume repletion is commonly accomplished on an empirical basis, without having a real insight of patient hemodynamic status, carrying the risk of possible volume overload.
Aim of the study is to test the clinical impact of two simple, non-invasive methods to guide volemic repletion before spinal anesthesia on the reduction of significant hypotension rate, compared to empirical fluid administration.
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Detailed Description
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Subarachnoidal administration of local anesthetics in fact is associated not only with both a motor and sensory block, but also with a blockade of the autonomic nervous system, which controls peripheral vascular tone. Sympathetic block leads to a sudden decrease in peripheral resistance, with consequent significant increase in vascular bed and relative hypovolemia.
Transient hypotensive episodes can be generally well tolerated by healthy patients, however they may lead to major complications in patients with increased cardiovascular risk. In the common clinical practice, it is usual to administer fluids empirically. An empirical preventive fluid repletion however can represent per se a risk in patients with impaired cardiac and renal functions, since a volume overload of heart chambers with reduced compliance can cause pulmonary edema or congestive heart failure.
Since about ten years both non-invasive and invasive techniques have been developed, with the specific purpose of optimizing fluid status on a rational basis. This methods are based on the correlation between the levels of mean arterial pressure (MAP), systemic vascular resistance (SVR) and cardiac output (CO), according to the equation: MAP = CO \* SVR. The latter explains why, in case of vasodilation, unless CO is increased, a lowering of SVR will inevitably translate into a decrease of MAP.
Determinants of blood pressure are:
1. volemic status;
2. vascular resistance (determined by the control of the sympathetic system);
3. cardiac output.
In case of spinal anesthesia the reduction in SVR determines relative hypovolemia (due to an increase in total vascular bed). For this reason after spinal anesthesia appears fundamental an optimization of patients' volemic status through administration of fluids (eventually associated with the administration of amines, in order to contrast massive vasodilation).
The use of methods to assess fluid responsiveness has been extensively studied in critical patients populations. However these techniques have not been studied yet in non critical patients. Spinal anesthesia is a model of pharmacological vasodilation which often generates significant hypotension, for which nowadays an evidence-based rational treatment based on a guided volemic repletion is still lacking.
WORKING HYPOTHESIS:
The use of non-invasive methods that have proven to be accurate for the identification of patient fluid-responsiveness is currently not validated in patients undergoing spinal anesthesia.
Ultrasound of inferior vena cava by is an effective method to determine the responsiveness to fluids in a patient on mechanical ventilation, however it has been proven to be inaccurate in spontaneous ventilating patients in critically ill patients, few data being available in non critical patients. The study of the inferior vena cava is based on the size of the inferior vena cava in its intra-abdominal portion (approximately 2 cm from emergency right atrium) and the pattern of its diameter changes with breathing. This measurement is obtained with M-mode ultrasound through subcostal view..
Passive leg raising test (PLRT) has been proven to be a highly accurate method in predicting fluid responsiveness in spontaneously breathing patients, in a population of critically ill patients. The method is based on the following assumption: active legs elevation, in addition to its effect of venous pool shifting from the lower limbs to the thorax, exerts a contemporary effect of stimulation on the peri-arterial sympathetic system at iliac-femoral level, this causing an orthosympathetic reflex which can increase cardiac output, possibly masking hypovolemia. Passive lower limbs raising instead has the advantage of mobilizing lower limbs venous blood (estimated 300-500 ml), without activating the orthosympathetic reflex. This allows for a quantification of the clinical response to a bolus of fluids, in terms of decrease of blood pressure variations following leg raising.
The hypothesis that investigators want to test is that the use of inferior vena cava ultrasound before spinal anesthesia, compared to the standard method (empirical fluid administration) and a non-invasive method (PLRT) can reduce the impact of systemic hypotension through an adequate titrated volemic repletion, avoiding both hypotension and fluid overload. The final purpose is to ensure spinal anesthesia in the safest possible way.
OBJECTIVES OF THE STUDY:
Aim of the study is to determine whether vena cava ultrasound, a bedside, unexpensive, non invasive methods, which have been tested as predictors of fluid responsiveness in critical patients, is effective in guiding titrated fluid repletion in a non critical population, in order both to decrease post procedural significant hypotension rate and unnecessary fluid overload in patients undergoing spinal anesthesia for elective surgical procedures.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Standard Clinical Practice
This arm is considered the current clinical standard for spinal anesthesia; its used as a control sample and statistical reference. During the induction phase the patient is fitted with a non-invasive blood pressure monitoring, three-lead ECG, pulse oximetry and peripheral intravenous device. The pressure control is set as the standard every 5 minutes until the procedure under spinal anesthesia, the cuff pressure is placed on the arm that is going to be on top during spinal anesthesia.
Data is recorded and vital signs of the patient and is put an infusion of crystalloid (0.9% NaCl or Ringer's acetate) with administration of 500 ml during the entire procedure until the beginning of the operation.
No interventions assigned to this group
Trans-thoracic echocardiography
In addition to the current clinical standard (arm A of the study) a trans-thoracic echocardiography is performed with the aim of assessing patient's volume status, identifying if he is responsive to fluid and could benefit from their administration. The echocardiography is performed with the subcostal projection to assess the size of the abdominal inferior vena cava and its collapsing during breathing.
According to different pre-established parameters, the patient is defined as unresponsive to fluids or responsive. If it's not responsive, he proceed to spinal anesthesia. Otherwise investigators proceed to the administration of crystalloid (NaCl 0.9% or Hartmann's solution second clinical evaluation) and at the end he's rerun an echocardiographic assessment.
Trans-thoracic echocardiography
Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not.
Passive Leg Raising Test
In addition to the arm A of the study, is performed a measurement of end-tidal CO2 (EtCO2) by trans-nasal canula with a patient positioned in semi-recumbent position. After, investigators run the Passive Leg Raising Test (PLRT): the position of the bed is changed in such manner to bring the trunk from 45° to 0° and accordingly the legs from 0° to 45°. Measurements are performed before and during the maneuver : an etCO2 increasing more than 12% from baseline was interpreted as fluid-responsive.
If the patient is not responsive to fluids, the patient is moving to the spinal anesthesia. If the patient is responsive investigators proceed to bolus administration, the patient returns to the initial PLRT position and is run again the PLRT until the patient is no longer responsive to fluids.
Passive Leg Raising Test
Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia.
Interventions
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Trans-thoracic echocardiography
Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not.
Passive Leg Raising Test
Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia.
Eligibility Criteria
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Inclusion Criteria
* both sex
* patients with American Society of Anesthesiology class level I, II and III according to international standards
* spontaneously breathing patients
Exclusion Criteria
* patients with pre-procedural hypotension, defined as a response in two consecutive measurements of systolic arterial pressure (SAP) less than 80 mmHg or mean arterial pressure (MAP) less of 60 mmHg.
* patients unable to give informed consent to communication difficulties to language barriers or processes congenital/acquired determinants of mental retard, or any reduction in their ability to understand or want to be able to give their informed consent to the study
* patients where it is not then possible to perform spinal anesthesia for the patient's refusal to technical difficulties in sampling, clinical pathological conditions for determining a high risk of peri- procedural complications.
* patients with International Normalized Ratio \> 1.5 and/or activated partial thromboplastin time in therapeutic range (defined as a value more than 1.5-2 times the normal values of the patient), anti-Xa activity in the therapeutic range .
* patients with severe thrombocytopenia (\<50 G/l)
18 Years
80 Years
ALL
No
Sponsors
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Ente Ospedaliero Cantonale, Bellinzona
OTHER
Responsible Party
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Samuele Ceruti
Capoclinica Medicina Intensiva
Principal Investigators
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Samuele Ceruti, MD
Role: PRINCIPAL_INVESTIGATOR
Ente Ospedaliero Cantonale - Ospedale Regionale di Bellinzona
Andrea Saporito, MD
Role: STUDY_CHAIR
Ente Ospedaliero Cantonale - Ospedale Regionale di Bellinzona
Locations
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Ospedale Regionale di Bellinzona e Valli (ORBV) - Sede Bellinzona
Bellinzona, , Switzerland
Countries
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References
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Kim HJ, Kim JS. A cardiovascular collapse following vigorous cough during spinal anesthesia. Korean J Anesthesiol. 2013 Dec;65(6 Suppl):S49-50. doi: 10.4097/kjae.2013.65.6S.S49. No abstract available.
Nogueira CS, Lima LC, Paris VC, Neiva PM, Otani ET, Couceiro Rde O, Burim F, Ferreira JA Jr, Cadecaro P. A comparative study between bupivacaine (S75-R25) and ropivacaine in spinal anesthesia for labor analgesia. Rev Bras Anestesiol. 2010 Sep-Oct;60(5):484-94. doi: 10.1016/S0034-7094(10)70060-X. English, Portuguese.
Xu S, Wu H, Zhao Q, Shen X, Guo X, Wang F. The median effective volume of crystalloid in preventing hypotension in patients undergoing cesarean delivery with spinal anesthesia. Rev Bras Anestesiol. 2012 May-Jun;62(3):312-24. doi: 10.1016/S0034-7094(12)70132-0.
Kaimar P, Sanji N, Upadya M, Mohammed KR. A comparison of hypotension and bradycardia following spinal anesthesia in patients on calcium channel blockers and beta-blockers. Indian J Pharmacol. 2012 Mar;44(2):193-6. doi: 10.4103/0253-7613.93847.
Zollei E, Bertalan V, Nemeth A, Csabi P, Laszlo I, Kaszaki J, Rudas L. Non-invasive detection of hypovolemia or fluid responsiveness in spontaneously breathing subjects. BMC Anesthesiol. 2013 Nov 5;13(1):40. doi: 10.1186/1471-2253-13-40.
Tulli G. Pulse pressure variation and stroke volume variation for prediction of fluid responsiveness in critically ill patients. Crit Care Med. 2013 Jan;41(1):e11. doi: 10.1097/CCM.0b013e318270e5a1. No abstract available.
Monge Garcia MI, Gil Cano A, Gracia Romero M, Monterroso Pintado R, Perez Madueno V, Diaz Monrove JC. Non-invasive assessment of fluid responsiveness by changes in partial end-tidal CO2 pressure during a passive leg-raising maneuver. Ann Intensive Care. 2012 Mar 26;2:9. doi: 10.1186/2110-5820-2-9.
Cherpanath TG, Geerts BF, Lagrand WK, Schultz MJ, Groeneveld AB. Basic concepts of fluid responsiveness. Neth Heart J. 2013 Dec;21(12):530-6. doi: 10.1007/s12471-013-0487-7.
Vieillard-Baron A, Chergui K, Rabiller A, Peyrouset O, Page B, Beauchet A, Jardin F. Superior vena caval collapsibility as a gauge of volume status in ventilated septic patients. Intensive Care Med. 2004 Sep;30(9):1734-9. doi: 10.1007/s00134-004-2361-y. Epub 2004 Jun 26.
Pinsky MR, Payen D. Functional hemodynamic monitoring. Crit Care. 2005;9(6):566-72. doi: 10.1186/cc3927. Epub 2005 Nov 22.
Lamia B, Ochagavia A, Monnet X, Chemla D, Richard C, Teboul JL. Echocardiographic prediction of volume responsiveness in critically ill patients with spontaneously breathing activity. Intensive Care Med. 2007 Jul;33(7):1125-1132. doi: 10.1007/s00134-007-0646-7. Epub 2007 May 17.
Muller L, Bobbia X, Toumi M, Louart G, Molinari N, Ragonnet B, Quintard H, Leone M, Zoric L, Lefrant JY; AzuRea group. Respiratory variations of inferior vena cava diameter to predict fluid responsiveness in spontaneously breathing patients with acute circulatory failure: need for a cautious use. Crit Care. 2012 Oct 8;16(5):R188. doi: 10.1186/cc11672.
Jabalameli M, Soltani HA, Hashemi J, Behdad S, Soleimani B. Prevention of post-spinal hypotension using crystalloid, colloid and ephedrine with three different combinations: A double blind randomized study. Adv Biomed Res. 2012;1:36. doi: 10.4103/2277-9175.100129. Epub 2012 Aug 28.
Buggy DJ, Power CK, Meeke R, O'Callaghan S, Moran C, O'Brien GT. Prevention of spinal anaesthesia-induced hypotension in the elderly: i.m. methoxamine or combined hetastarch and crystalloid. Br J Anaesth. 1998 Feb;80(2):199-203. doi: 10.1093/bja/80.2.199.
Zhang Z, Xu X, Ye S, Xu L. Ultrasonographic measurement of the respiratory variation in the inferior vena cava diameter is predictive of fluid responsiveness in critically ill patients: systematic review and meta-analysis. Ultrasound Med Biol. 2014 May;40(5):845-53. doi: 10.1016/j.ultrasmedbio.2013.12.010. Epub 2014 Feb 2.
Bodson L, Vieillard-Baron A. Respiratory variation in inferior vena cava diameter: surrogate of central venous pressure or parameter of fluid responsiveness? Let the physiology reply. Crit Care. 2012 Nov 28;16(6):181. doi: 10.1186/cc11824.
Schmidt GA, Kory P. Ultrasound-guided central venous catheter insertion: teaching and learning. Intensive Care Med. 2014 Jan;40(1):111-3. doi: 10.1007/s00134-013-3093-7. Epub 2013 Sep 7. No abstract available.
Carpenter RL, Caplan RA, Brown DL, Stephenson C, Wu R. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992 Jun;76(6):906-16. doi: 10.1097/00000542-199206000-00006.
Marik PE. Techniques for assessment of intravascular volume in critically ill patients. J Intensive Care Med. 2009 Sep-Oct;24(5):329-37. doi: 10.1177/0885066609340640.
Funk DJ, Moretti EW, Gan TJ. Minimally invasive cardiac output monitoring in the perioperative setting. Anesth Analg. 2009 Mar;108(3):887-97. doi: 10.1213/ane.0b013e31818ffd99.
Barbier C, Loubieres Y, Schmit C, Hayon J, Ricome JL, Jardin F, Vieillard-Baron A. Respiratory changes in inferior vena cava diameter are helpful in predicting fluid responsiveness in ventilated septic patients. Intensive Care Med. 2004 Sep;30(9):1740-6. doi: 10.1007/s00134-004-2259-8. Epub 2004 Mar 18.
Ceruti S, Minotti B, De Vivo S, De Christophoris P, Anselmi L, Saporito A. PROtocolized care to reduce HYpotension after spinal anaesthesia (ProCRHYSA randomized trial): Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2016 Jun 29;4:39-45. doi: 10.1016/j.conctc.2016.06.012. eCollection 2016 Dec 15.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Swiss Ethic
Cantonal Ethic Committee
Other Identifiers
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ProCRHYSA trial
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CERU-1401
Identifier Type: -
Identifier Source: org_study_id
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