Predict Fluid Responsiveness in Spinal Anesthesia

NCT02070276 | Completed Results DMC

• 2 other identifiers: CERU-1401ProCRHYSA trial
• Study Type: interventional
• Target: 429
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia is still the regional anesthesia technique most widely employed in everyday clinical practice. 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.

Conditions

Hypotension and Shock; Excessive Amount of Blood / Fluid Infusion

Keywords

Fluid therapy; Hypotension; Inferior vein cava; Spinal anesthesia; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Systemic Hypotensions

  Primary objective is to quantify significant hypotension rate after spinal anesthesia in patients brought to euvolemia according to the Trans-Thoracic Echocardiography and PLRT (Passive Leg Raising Test), compared to patients treated with the current standard. For arterial hypotension, in accordance with the international standard definitions, now define a drop in systolic blood pressure over 50 mmHg from baseline, an absolute value of systolic blood pressure less than 80 mm Hg, a mean arterial pressure below 60 mmHg or hypotension clinically symptomatic (dizziness, pallor, sweating, nausea).

  30 minutes

Secondary Outcomes (2)

• Pre-anesthesia Fluid Amount

  Time between operating room entry and spinal anesthesia, up to 30 min.

• Post-anesthesia Fluid Amount

  30 minutes

Study Arms (3)

Standard Clinical Practice

NO INTERVENTION

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.

Trans-thoracic echocardiography

EXPERIMENTAL

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.

Procedure: Trans-thoracic echocardiography

Passive Leg Raising Test

EXPERIMENTAL

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.

Procedure: Passive Leg Raising Test

Interventions

Trans-thoracic echocardiography PROCEDURE

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.

Trans-thoracic echocardiography

Passive Leg Raising Test PROCEDURE

Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia.

Passive Leg Raising Test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all adult non critical patients requiring elective spinal anesthesia
• both sex
• patients with American Society of Anesthesiology class level I, II and III according to international standards
• spontaneously breathing patients

You may not qualify if:

• patients already equipped or requiring invasive blood pressure monitoring (arterial catheter, pulmonary catheter, thermodilution catheter)
• 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)

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

Ospedale Regionale di Bellinzona e Valli (ORBV) - Sede Bellinzona

Bellinzona, 6500, Switzerland

Location

Related Publications (22)

• 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.

  PMID: 24478870 BACKGROUND

• 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.

  PMID: 20863929 BACKGROUND

• 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.

  PMID: 22656677 BACKGROUND

• 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.

  PMID: 22529474 BACKGROUND

• 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.

  PMID: 24188480 BACKGROUND

• 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.

  PMID: 23269163 BACKGROUND

• 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.

  PMID: 22449292 BACKGROUND

• 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.

  PMID: 24170232 BACKGROUND

• 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.

  PMID: 15375649 BACKGROUND

• Pinsky MR, Payen D. Functional hemodynamic monitoring. Crit Care. 2005;9(6):566-72. doi: 10.1186/cc3927. Epub 2005 Nov 22.

  PMID: 16356240 BACKGROUND

• 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.

  PMID: 17508199 BACKGROUND

• 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.

  PMID: 23043910 BACKGROUND

• 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.

  PMID: 23326767 BACKGROUND

• 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.

  PMID: 9602585 BACKGROUND

• 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.

  PMID: 24495437 BACKGROUND

• 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.

  PMID: 23185986 BACKGROUND

• 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.

  PMID: 24013437 BACKGROUND

• 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.

  PMID: 1599111 BACKGROUND

• 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.

  PMID: 19648183 BACKGROUND

• 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.

  PMID: 19224798 BACKGROUND

• 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.

  PMID: 15034650 BACKGROUND

• 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.

  PMID: 29736468 DERIVED

Related Links

• Swiss Ethic
• Cantonal Ethic Committee

MeSH Terms

Conditions

Hypotension; Shock

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

* single-centre study * impossible to blind patients about their group allocation * ultrasounds could be not feasible in a certain amount of patients due to poor ultrasound windows * we included only American Society Anesthesiology I-III patients

Results Point of Contact

• Title: Dr. med. Samuele Ceruti
• Organization: Hôpitaux Universitaires de Genève

samuele.ceruti@me.com

0765661181

Study Officials

• Samuele Ceruti, MD

  Ente Ospedaliero Cantonale - Ospedale Regionale di Bellinzona

  PRINCIPAL INVESTIGATOR

• Andrea Saporito, MD

  Ente Ospedaliero Cantonale - Ospedale Regionale di Bellinzona

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Capoclinica Medicina Intensiva

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 25, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: August 1, 2019
• Last Updated: July 13, 2020
• Results First Posted: December 19, 2019

Record last verified: 2020-07

Locations

CH (1)