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

H

Hopital Foch

Status

Completed

Conditions

Fluid Responsiveness

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02040948
2011/56
2011-A01294-37 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

68 participants in 1 patient group

Surgical patients
Experimental group
Description:
* Nexfin (Pulse Pressure Variation) * Radical 7 (Pleth Variability Index) * CardioQ (stroke volume)
Treatment:
Device: - Nexfin (Pulse Pressure Variation) - Radical 7 (Pleth Variability Index) - CardioQ (stroke volume)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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