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NCT02040948 Clinical Trial

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

Fluid Responsiveness Clinical Trial

— Nexfin2  

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02040948
Other study ID # 2011/56
Secondary ID 2011-A01294-37
Status Completed
Phase N/A
First received January 15, 2014
Last updated November 2, 2016
Start date June 2013
Est. completion date May 2014

Study information
Verified date November 2016
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hopital Beaujon Clichy Hauts de Seine
France Hopital Foch Suresnes Hauts de Seine

Sponsors (1)
Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Inability to obtain Pleth Variability Index or Pulse Pressure Variation indices during the intraoperative period No
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