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

Not Applicable

Completed

• Conditions: Fluid Responsiveness
• Interventions: Device: - Nexfin (Pulse Pressure Variation) - Radical 7 (Pleth Variability Index) - CardioQ (stroke volume)

• Registration Number: NCT02040948
• Lead Sponsor: Hopital Foch

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical patients	- Nexfin (Pulse Pressure Variation) - Radical 7 (Pleth Variability Index) - CardioQ (stroke volume)	* Nexfin (Pulse Pressure Variation) * Radical 7 (Pleth Variability Index) * CardioQ (stroke volume)

Primary Outcome Measures

Name	Time	Method
Ability of Pleth Variability Index and of Pulse Pressure Variation to detect the response to a fluid challenge	during the intraoperative period	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)

Secondary Outcome Measures

Name	Time	Method
Inability to obtain Pleth Variability Index or Pulse Pressure Variation indices	during the intraoperative period

Trial Locations

Locations (2)

Hopital Foch; 🇫🇷 Suresnes, Hauts de Seine, France

Hopital Beaujon; 🇫🇷 Clichy, Hauts de Seine, France