The Application of Pleth Variability Index in Continuous Monitoring the Volume Status of Intraoperative Patients

The Application of Pleth Variability Index in Continuous Monitoring Volume Status in Patients Undergoing Intestinal Tumor Surgery

To assess the value of using pleth variability index(PVI) to monitor the patient's intra-operative volume status continuously by observing the application of stroke volume variation(SVV) and PVI and their correlation in patients undergoing intestinal tumor surgeries.

Study Overview

• Status: Unknown
• Conditions: Hemodynamic Monitoring

Detailed Description

Objective: To assess the value of using PVI to monitor the patient's intra-operative volume status continuously by observing the application of stroke volume variation(SVV) and pleth variability index(PVI) and their correlation in patients undergoing intestinal tumor surgeries.

Methods: 50 patients undergoing elective intestinal tumor surgery were enrolled, ASAⅠ-Ⅲ, aged 18-65 years. After the induction of general anesthesia, cardiac index(CI), cardiac output(CO), stroke volume variability(SVV), stroke volume index(SVI) were monitored with Vigileo system, while pleth variability index(PVI) and perfusion index(PI) were monitored with Massion Radical 7 system. During the surgery, goal directed fluid therapy was conducted according to the data of CI、SVI and SVV. Heart rate(HR), mean arterial pressure(MAP), central venous pressure(CVP), CO, CI, SVI, SVV, PI, PVI were recorded while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4). And we calculate the correlation of SVV and PVI using Pearson Correlation Analysis at different time points.

• Study Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

50 patients undergoing elective intestinal tumor surgery were enrolled, ASAⅠ-Ⅲ,aged 18-65 years,BMI 18~30kg/㎡.

Description

Inclusion Criteria:

• patients undergoing elective intestinal tumor surgery
• American Society of Anesthesiologists (ASA) physical status of grade I-Ⅲ
• Aged 18-65 years
• BMI 18~30kg/㎡

Exclusion Criteria:

• Patients under 18 years or above 65 years
• patients with severe aortic regurgitation
• patients with permanent cardiac arrhythmias
• patients with intra-aortic balloon pump
• patients with severe pulmonary disease
• patients undergoing emergency surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the correlation of SVV and PVI	SVV and PVI were recorded while after the induction of anesthesia(T1),making surgical incision(T2),performing intestinal anastomosis(T3) and closing the abdominal incision(T4). We calculate the correlation of SVV and PVI using Pearson Correlation Analysis at different time points.	during the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stroke volume variability(SVV)	stroke volume variability(SVV) in percentage.Record the date of SVV while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of SVV between the time points.	during the surgery
pleth variability index(PVI)	pleth variability index(PVI) in percentage.Record the date of PVI while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of PVI between the time points.	during the surgery
pleth index(PI)	pleth index(PI) in percentage.Record the date of PI while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of PI between the time points.	during the surgery
cardiac index(CI)	cardiac index(CI) in L•min-1•m-2.Record the date of CI while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of CI between the time points.	during the surgery
stroke volume index(SVI)	(SVI) in ml•m-2.Record the date of SVI while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of SVI between the time points.	during the surgery

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Collaborators: Guangzhou Panyu Central Hospital

Publications and helpful links

General Publications

• Zimmermann M, Feibicke T, Keyl C, Prasser C, Moritz S, Graf BM, Wiesenack C. Accuracy of stroke volume variation compared with pleth variability index to predict fluid responsiveness in mechanically ventilated patients undergoing major surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. doi: 10.1097/EJA.0b013e328335fbd1.
• Brandstrup B. Fluid therapy for the surgical patient. Best Pract Res Clin Anaesthesiol. 2006 Jun;20(2):265-83. doi: 10.1016/j.bpa.2005.10.007.
• Grocott MPW, Mythen MG, Gan TJ. Perioperative fluid management and clinical outcomes in adults. Anesth Analg. 2005 Apr;100(4):1093-1106. doi: 10.1213/01.ANE.0000148691.33690.AC.
• Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005 Jul;103(1):25-32. doi: 10.1097/00000542-200507000-00008.
• Strunden MS, Heckel K, Goetz AE, Reuter DA. Perioperative fluid and volume management: physiological basis, tools and strategies. Ann Intensive Care. 2011 Mar 21;1(1):2. doi: 10.1186/2110-5820-1-2.
• Samra T, Arya VK. Comparison of cardiac output estimation by FloTrac/Vigileo TM and intermittent pulmonary artery thermodilution in patient with Takayasu arteritis. Ann Card Anaesth. 2011 May-Aug;14(2):163-4. doi: 10.4103/0971-9784.81579. No abstract available.
• Cannesson M. Arterial pressure variation and goal-directed fluid therapy. J Cardiothorac Vasc Anesth. 2010 Jun;24(3):487-97. doi: 10.1053/j.jvca.2009.10.008. No abstract available.
• Mathews L, Singh RK. Cardiac output monitoring. Ann Card Anaesth. 2008 Jan-Jun;11(1):56-68. doi: 10.4103/0971-9784.38455.
• Cannesson M, Attof Y, Rosamel P, Joseph P, Bastien O, Lehot JJ. Comparison of FloTrac cardiac output monitoring system in patients undergoing coronary artery bypass grafting with pulmonary artery cardiac output measurements. Eur J Anaesthesiol. 2007 Oct;24(10):832-9. doi: 10.1017/S0265021507001056. Epub 2007 Aug 1.
• Rex S, Brose S, Metzelder S, Huneke R, Schalte G, Autschbach R, Rossaint R, Buhre W. Prediction of fluid responsiveness in patients during cardiac surgery. Br J Anaesth. 2004 Dec;93(6):782-8. doi: 10.1093/bja/aeh280. Epub 2004 Oct 1.
• Michard F, Alaya S, Zarka V, Bahloul M, Richard C, Teboul JL. Global end-diastolic volume as an indicator of cardiac preload in patients with septic shock. Chest. 2003 Nov;124(5):1900-8. doi: 10.1378/chest.124.5.1900.
• Mayer J, Boldt J, Mengistu AM, Rohm KD, Suttner S. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Crit Care. 2010;14(1):R18. doi: 10.1186/cc8875. Epub 2010 Feb 15.
• Haas S, Trepte C, Hinteregger M, Fahje R, Sill B, Herich L, Reuter DA. Prediction of volume responsiveness using pleth variability index in patients undergoing cardiac surgery after cardiopulmonary bypass. J Anesth. 2012 Oct;26(5):696-701. doi: 10.1007/s00540-012-1410-x. Epub 2012 May 16.
• Desgranges FP, Desebbe O, Ghazouani A, Gilbert K, Keller G, Chiari P, Robin J, Bastien O, Lehot JJ, Cannesson M. Influence of the site of measurement on the ability of plethysmographic variability index to predict fluid responsiveness. Br J Anaesth. 2011 Sep;107(3):329-35. doi: 10.1093/bja/aer165. Epub 2011 Jun 16.
• Monnet X, Teboul JL. Volume responsiveness. Curr Opin Crit Care. 2007 Oct;13(5):549-53. doi: 10.1097/MCC.0b013e3282ec68b2.
• Sandroni C, Cavallaro F, Marano C, Falcone C, De Santis P, Antonelli M. Accuracy of plethysmographic indices as predictors of fluid responsiveness in mechanically ventilated adults: a systematic review and meta-analysis. Intensive Care Med. 2012 Sep;38(9):1429-37. doi: 10.1007/s00134-012-2621-1. Epub 2012 Jun 26.
• Schoonjans A, Forget P, Labriola L, Deneys V, Jadoul M, Pingaut I, De Kock M. Pleth variability index combined with passive leg raising-induced pulse pressure variation to detect hypovolemia in spontaneously breathing patients. Acta Anaesthesiol Belg. 2010;61(3):147-50.
• Takeyama M, Matsunaga A, Kakihana Y, Masuda M, Kuniyoshi T, Kanmura Y. Impact of skin incision on the pleth variability index. J Clin Monit Comput. 2011 Aug;25(4):215-21. doi: 10.1007/s10877-011-9298-9. Epub 2011 Sep 18.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: December 30, 2016
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: stroke volume variation; intraoperative; pleth variability index; perfusion Index; intestinal tumor
• Other Study ID Numbers: H20160049（01）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED