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

Hemodynamic Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03009669
• Other study ID #: H20160049(01)
• Status: Active, not recruiting
• Phase: N/A
• First received: December 30, 2016
• Last updated: January 3, 2017
• Start date: December 2016
• Est. completion date: September 2017

Study information

• Verified date: December 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:Health and Family Planning Commission of the Guangzhou
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: September 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients undergoing elective intestinal tumor surgery

• American Society of Anesthesiologists (ASA) physical status of grade I-?

• 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemodynamic Monitoring

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University	Guangzhou Panyu Central Hospital

References & Publications (18)

Brandstrup B. Fluid therapy for the surgical patient. Best Pract Res Clin Anaesthesiol. 2006 Jun;20(2):265-83. Review. — View Citation

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;2 — View Citation

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. Review. — View Citation

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 — View Citation

Grocott MP, Mythen MG, Gan TJ. Perioperative fluid management and clinical outcomes in adults. Anesth Analg. 2005 Apr;100(4):1093-106. Review. — View Citation

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/s0 — View Citation

Mathews L, Singh RK. Cardiac output monitoring. Ann Card Anaesth. 2008 Jan-Jun;11(1):56-68. Review. — View Citation

Mayer J, Boldt J, Mengistu AM, Röhm 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) — View Citation

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. — View Citation

Monnet X, Teboul JL. Volume responsiveness. Curr Opin Crit Care. 2007 Oct;13(5):549-53. Review. — View Citation

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. — View Citation

Rex S, Brose S, Metzelder S, Hüneke R, Schälte 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. — View Citation

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. — View Citation

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) — View Citation

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. 201 — View Citation

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. — View Citation

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. — View Citation

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 Anae — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No