Accuracy of Pulse Pressure Variation and of Pleth Variability Index to Predict the Response to a Fluid Challenge
Nexfin2
2 other identifiers
interventional
68
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 15, 2014
CompletedFirst Posted
Study publicly available on registry
January 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedNovember 3, 2016
November 1, 2016
11 months
January 15, 2014
November 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Inability to obtain Pleth Variability Index or Pulse Pressure Variation indices
during the intraoperative period
Study Arms (1)
Surgical patients
EXPERIMENTAL* Nexfin (Pulse Pressure Variation) * Radical 7 (Pleth Variability Index) * CardioQ (stroke volume)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (2)
Hopital Beaujon
Clichy, Hauts de Seine, 92110, France
Hopital Foch
Suresnes, Hauts de Seine, 92151, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2014
First Posted
January 20, 2014
Study Start
June 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
November 3, 2016
Record last verified: 2016-11