Comparison of Transthoracic Electrical Bioimpedance and Pulse Contour Analysis in Renal Transplantation Patients

Hemodynamic Monitoring Clinical Trial

Official title:

Comparison of Transthoracic Electrical Bioimpedance and Pulse Contour Analysis in Renal Transplantation Patients: Analysis of Intraoperative Cardiac Output, Systemic Vascular Resistant and Stroke Volume Variation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03893513
• Other study ID #: IndonesiaUAnes032
• Status: Completed
• Start date: March 12, 2019
• Est. completion date: May 12, 2019

Study information

• Verified date: June 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hemodynamics monitoring using non-invasive transthoracic electrical bioimpedance ICON are compatible with standard invasive monitoring using pulse contour analysis EV1000

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 12, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• BMI 18.5 - 35 kg/m^2

Exclusion Criteria:

• Heart function abnormalities (arrhythmia, AV block, using pacemaker, severe aorta stenosis)

• Morbid obesity

• Bradycardia (< 50 bpm)

• Tachycardia (> 110 bpm)

• refuse to participate

Related Conditions & MeSH terms

• Hemodynamic Monitoring

Intervention

Device:
• Transthoracic Electrical Bioimpedance
Non-invasive hemodynamic monitor
• Pulse Contour Analysis
Invasive hemodynamic monitor

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dita Aditianingsih

Country where clinical trial is conducted

Indonesia, 

References & Publications (27)

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Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21. Review. — View Citation

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Mehta Y, Arora D. Newer methods of cardiac output monitoring. World J Cardiol. 2014 Sep 26;6(9):1022-9. doi: 10.4330/wjc.v6.i9.1022. Review. — View Citation

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Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305. Erratum in: JAMA. 2014 Oct 8;312(14):1473. — View Citation

Peyton PJ, Chong SW. Minimally invasive measurement of cardiac output during surgery and critical care: a meta-analysis of accuracy and precision. Anesthesiology. 2010 Nov;113(5):1220-35. doi: 10.1097/ALN.0b013e3181ee3130. Review. Erratum in: Anesthesiology. 2012 Apr;116(4):973. — View Citation

Porhomayon J, El-Solh A, Papadakos P, Nader ND. Cardiac output monitoring devices: an analytic review. Intern Emerg Med. 2012 Apr;7(2):163-71. doi: 10.1007/s11739-011-0738-9. Epub 2011 Dec 7. Review. — View Citation

Saugel B, Cecconi M, Wagner JY, Reuter DA. Noninvasive continuous cardiac output monitoring in perioperative and intensive care medicine. Br J Anaesth. 2015 Apr;114(4):562-75. doi: 10.1093/bja/aeu447. Epub 2015 Jan 16. Review. — View Citation

Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. — View Citation

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Suttner S, Schöllhorn T, Boldt J, Mayer J, Röhm KD, Lang K, Piper SN. Noninvasive assessment of cardiac output using thoracic electrical bioimpedance in hemodynamically stable and unstable patients after cardiac surgery: a comparison with pulmonary artery thermodilution. Intensive Care Med. 2006 Dec;32(12):2053-8. Epub 2006 Oct 13. Retraction in: Intensive Care Med. 2011 Jul;37(7):1232. — View Citation

Vincent JL, Pelosi P, Pearse R, Payen D, Perel A, Hoeft A, Romagnoli S, Ranieri VM, Ichai C, Forget P, Della Rocca G, Rhodes A. Perioperative cardiovascular monitoring of high-risk patients: a consensus of 12. Crit Care. 2015 May 8;19:224. doi: 10.1186/s13054-015-0932-7. Review. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic correlation	Correlation between hemodynamic measured between devices: cardiac index, stroke volume index, systemic vascular resistance index, stroke volume index	Intraoperative
Secondary	Changes in hemodynamic profiles: Cardiac Index	The trends of perioperative hemodynamic profiles during and after surgery: cardiac index in L/minutes/m^2	Intraoperative
Secondary	Changes in hemodynamic profiles: Stroke Volume Index	The trends of perioperative haemodynamic profiles during and after surgery: stroke volume index in mL/beat/m^2	Intraoperative
Secondary	Changes in hemodynamic profiles: Systemic Vascular Resistance Index	The trends of perioperative haemodynamic profiles during and after surgery: systemic vascular resistance index in dynes-second-m^2/cm^5	Intraoperative
Secondary	Changes in hemodynamic profiles: Stroke Volume Variation	The trends of perioperative haemodynamic profiles during and after surgery: stroke volume variation in %	Intraoperative