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

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02040948

Acronym

Nexfin2

Enrollment

Registered

2014-01-20

Start date

2013-06-30

Completion date

2014-05-31

Last updated

2016-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Responsiveness

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.

Interventions

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026