The Application of Pleth Variability Index in Continuous Monitoring the Volume Status of Intraoperative Patients
NCT ID: NCT03009669
Last Updated: 2017-01-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
50 participants
Study Classification
OBSERVATIONAL
Study Start Date
2016-12-31
Study Completion Date
2017-09-30
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Hemodynamic Monitoring
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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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/㎡
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Guangzhou Panyu Central Hospital
OTHER
Sponsor Role
collaborator
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Sponsor Role
lead
Responsible Party
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Lin Yang
attending physician
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Shu HaiHua, doctor
Role: STUDY_CHAIR
First Affiliated Hospital, Sun Yat-Sen University
References
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Mathews L, Singh RK. Cardiac output monitoring. Ann Card Anaesth. 2008 Jan-Jun;11(1):56-68. doi: 10.4103/0971-9784.38455.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Monnet X, Teboul JL. Volume responsiveness. Curr Opin Crit Care. 2007 Oct;13(5):549-53. doi: 10.1097/MCC.0b013e3282ec68b2.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Other Identifiers
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H20160049（01）
Identifier Type: -
Identifier Source: org_study_id
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