Accuracy of Pulse Pressure Variation and of Pleth Variability Index to Predict the Response to a Fluid Challenge (Nexfin2)

Accuracy of Pulse Pressure Variation (Nexfin) and of Pleth Variability Index (Radical 7) to Predict the Response to a Fluid Challenge: Comparison With the Reference Method (Measurement of Stroke Volume by Esophageal Doppler)

The aim of this study is to compare the accuracy of Pleth Variability Index (Radical 7 device) and of Pulse Pressure Variation (Nexfin device) with the Doppler measurement of stroke volume (esophageal Doppler) to detect the response to a fluid challenge.

Study Overview

• Status: Completed
• Conditions: Fluid Responsiveness
• Intervention / Treatment: Device: - Nexfin (Pulse Pressure Variation) - Radical 7 (Pleth Variability Index) - CardioQ (stroke volume)

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hauts de Seine
    • Clichy, Hauts de Seine, France, 92110
      • Hopital Beaujon
    • Suresnes, Hauts de Seine, France, 92151
      • Hôpital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergoing major abdominal surgical procedures performed by laparotomy
• patients undergoing major urological surgical procedures performed by laparotomy
• patients undergoing major gynecological surgical procedures performed by laparotomy
• age ≥ 18 years
• signed informed consent

Exclusion Criteria:

• pregnant women
• esophageal disease
• aortic valve disease
• allergy to gelatin
• BMI > 35
• beta blocker treatment, antiarrhythmic treatment, arrhythmia, pace-maker,
• presence of an arterio-venous shunt or of any other vascular disease on upper limb

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgical patients; Nexfin (Pulse Pressure Variation); Radical 7 (Pleth Variability Index); CardioQ (stroke volume)	Device: - Nexfin (Pulse Pressure Variation) - Radical 7 (Pleth Variability Index) - CardioQ (stroke volume)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of Pleth Variability Index and of Pulse Pressure Variation to detect the response to a fluid challenge	Three fluid challenges, 250 mL of a gelatine solution, are planned. Pleth Variability Index and Pulse Pressure Variation are compared to the measurement of stroke volume by Esophageal Doppler (the reference method)	during the intraoperative period

Secondary Outcome Measures

Outcome Measure	Time Frame
Inability to obtain Pleth Variability Index or Pulse Pressure Variation indices	during the intraoperative period

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: January 15, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Estimate): November 3, 2016
• Last Update Submitted That Met QC Criteria: November 2, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2011/56; 2011-A01294-37 (Other Identifier: ANSM)