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

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ClinicalTrials.gov Identifier: NCT02040948
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fluid Responsiveness Device: - Nexfin (Pulse Pressure Variation) - Radical 7 (Pleth Variability Index) - CardioQ (stroke volume) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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)
Study Start Date : June 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014
Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Ability of Pleth Variability Index and of Pulse Pressure Variation to detect the response to a fluid challenge [ Time Frame: 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 :
  1. Inability to obtain Pleth Variability Index or Pulse Pressure Variation indices [ Time Frame: during the intraoperative period ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040948


Locations
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France
Hopital Beaujon
Clichy, Hauts de Seine, France, 92110
Hopital Foch
Suresnes, Hauts de Seine, France, 92151
Sponsors and Collaborators
Hopital Foch
More Information
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02040948    
Other Study ID Numbers: 2011/56
2011-A01294-37 ( Other Identifier: ANSM )
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016