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Clinical Trials/NCT03499860
NCT03499860
Completed
Not Applicable

Prediction of Fluid Responsiveness From Passive Leg Raising Induced Changes in Perfusion Index and Pleth Variability Index

Institute of Mountain Emergency Medicine1 site in 1 country51 target enrollmentApril 20, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fluid Responsiveness
Sponsor
Institute of Mountain Emergency Medicine
Enrollment
51
Locations
1
Primary Endpoint
PI difference
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The aim of the study is to evaluate whether changes in Perfusion Index (PI) and Pleth Variability Index (PVI) during passive leg raising test can predict fluid responsiveness in spontaneously breathing patients.

Fluid responsive patients are defined as showing an increase in cardiac output >10% during a passive leg raising test, measured semi-invaseively with FloTrac® (Edwards LifeSciences. Irvine, United States).

Registry
clinicaltrials.gov
Start Date
April 20, 2018
End Date
April 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Institute of Mountain Emergency Medicine
Responsible Party
Principal Investigator
Principal Investigator

Simon Rauch

Researcher

Institute of Mountain Emergency Medicine

Eligibility Criteria

Inclusion Criteria

  • Adult patients admitted to the intensive or intermediate care unit after abdominal surgery (including urological and gynecological surgery performed in laparotomy)
  • Spontaneous breathing
  • Arterial line already in place
  • Oral and written informed consent obtained

Exclusion Criteria

  • Age \<18 years
  • Abdominal trauma as the reason for surgery
  • Missing informed consent

Outcomes

Primary Outcomes

PI difference

Time Frame: 90 seconds

Difference in the change of perfusion index from baseline during a passive leg raising maneuver in fluid responsive patients compared to fluid non-responders

PVI difference

Time Frame: 90 seconds

Difference in the change of pleth variability index from baseline during a passive leg raising maneuver in fluid responsive patients compared to fluid non-responders

Study Sites (1)

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