PVI as a Parameter to Predict Fluid Responsiveness

Surgery Clinical Trial

— PVI  

Official title:

Validation of PVI as a Parameter to Predict Fluid Responsiveness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03075150
• Other study ID #: 930087
• Secondary ID: FLEM0005
• Status: Recruiting
• Start date: December 15, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2019
• Source: University of California, Davis
• Contact: Neal Fleming, MD, PhD
• Phone: 916-734-5046
• Email: nwfleming[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, randomized, sequential data collection study to evaluate the ability of pleth variability index (PVI) to predict fluid responsiveness in comparison with other dynamic parameters including pulse pressure variation (PPV) and stroke volume variation (SVV).

Description:

Patients will be randomized to a tidal volume of either 6 or 8 ml.kg-1 of ideal body weight, with positive end-expiratory pressure set between 3 and 5 cmH20.

The finger sensor will be applied to patients in the OR, and hemodynamic measurements will be collected from standard OR monitors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Scheduled for elective surgery requiring general anesthesia and mechanical ventilation

• Arterial line and Swan-Ganz catheter placed as part of the scheduled surgical procedure

Exclusion Criteria:

• Patients with surgeries at or around site of sensor placement

• Skin abnormalities affecting the sensor placement area

• Patients with cardiac arrhythmias

• Patients with intracardiac shunts

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Masimo Rainbow sensor
The Masimo Rainbow is a portable handheld device connected to a sensor that measures SpHb, SpO2, pulse rate (PR) and perfusion index (PI) in addition to pleth variability index (rPVI).

Locations

Country	Name	City	State
United States	UC Davis Health	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Masimo Corporation

Country where clinical trial is conducted

United States, 

References & Publications (7)

Desebbe O, Boucau C, Farhat F, Bastien O, Lehot JJ, Cannesson M. The ability of pleth variability index to predict the hemodynamic effects of positive end-expiratory pressure in mechanically ventilated patients under general anesthesia. Anesth Analg. 2010 Mar 1;110(3):792-8. doi: 10.1213/ANE.0b013e3181cd6d06. — View Citation

Desebbe O, Cannesson M. Using ventilation-induced plethysmographic variations to optimize patient fluid status. Curr Opin Anaesthesiol. 2008 Dec;21(6):772-8. doi: 10.1097/ACO.0b013e32831504ca. Review. — View Citation

Gurgel ST, do Nascimento P Jr. Maintaining tissue perfusion in high-risk surgical patients: a systematic review of randomized clinical trials. Anesth Analg. 2011 Jun;112(6):1384-91. doi: 10.1213/ANE.0b013e3182055384. Epub 2010 Dec 14. Review. — View Citation

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

Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da. Review. — 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):1429-37. doi: 10.1007/s00134-012-2621-1. Epub 2012 Jun 26. Review. — View Citation

Yin JY, Ho KM. Use of plethysmographic variability index derived from the Massimo(®) pulse oximeter to predict fluid or preload responsiveness: a systematic review and meta-analysis. Anaesthesia. 2012 Jul;67(7):777-83. doi: 10.1111/j.1365-2044.2012.07117.x. Epub 2012 Mar 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Utility of pleth variability index (PVI)	PVI as a predictor of fluid responsiveness in mechanically ventilated patients at two specific tidal volumes (6 ml/kg IBW and 8 ml/kg IBW)	1 year

External Links

•   Assessment of Trending Ability of Cardiac Output Monitors by Polar Plot Methodology
•   Changes in Arterial Pressure during Mechanical Ventilation