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

NCT03009669 | Unknown DMC

• 1 other identifier: H20160049（01）
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hemodynamic Monitoring

Keywords

pleth variability index; stroke volume variation; perfusion Index; intraoperative; intestinal tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• stroke volume variability(SVV)

  during the surgery

• pleth variability index(PVI)

  during the surgery

• pleth index(PI)

  during the surgery

• cardiac index(CI)

  during the surgery

• stroke volume index(SVI)

  during the surgery

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead
• Guangzhou Panyu Central Hospital: collaborator

Related Publications (18)

• 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.

  PMID: 16850777 RESULT

• 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.

  PMID: 15781528 RESULT

• 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.

  PMID: 15983453 RESULT

• 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.

  PMID: 21906324 RESULT

• 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.

  PMID: 21636945 RESULT

• 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.

  PMID: 20022261 RESULT

• Mathews L, Singh RK. Cardiac output monitoring. Ann Card Anaesth. 2008 Jan-Jun;11(1):56-68. doi: 10.4103/0971-9784.38455.

  PMID: 18182765 RESULT

• 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.

  PMID: 17666154 RESULT

• 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.

  PMID: 15465840 RESULT

• 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.

  PMID: 14605066 RESULT

• 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.

  PMID: 20156348 RESULT

• 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.

  PMID: 22588287 RESULT

• 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.

  PMID: 20035228 RESULT

• 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.

  PMID: 21680600 RESULT

• Monnet X, Teboul JL. Volume responsiveness. Curr Opin Crit Care. 2007 Oct;13(5):549-53. doi: 10.1097/MCC.0b013e3282ec68b2.

  PMID: 17762234 RESULT

• 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.

  PMID: 22732902 RESULT

• 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.

  PMID: 21268570 RESULT

• 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.

  PMID: 21928109 RESULT

MeSH Terms

Conditions

Intestinal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases

Study Officials

• Shu HaiHua, doctor

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: January 4, 2017
• Study Start: December 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 4, 2017

Record last verified: 2016-12