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Completed

NCT Number: NCT02040948

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

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.

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Key information

Conditions

Fluid Responsiveness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Beaujon, Clichy, Hauts de Seine, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Primary outcomes

  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 outcomes

  1. Inability to obtain Pleth Variability Index or Pulse Pressure Variation indices

    Time frame: during the intraoperative period

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study 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)

Acronym: Nexfin2

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2014
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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