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OpenTrials
Completed

NCT Number: NCT03499860

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

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).

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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

"F. Tappeiner" Hospital Merano

Merano, Bolzano, 39012, Italy

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Passive Leg Raising Test

Diagnostic Test

A passive leg raising test is performed in all patients included in the study

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Institute of Mountain Emergency Medicine

Other

Collaborators

  • Department of Anaesthesiology, Merano Hospital, Italy

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2018
Registry last updated
Jul 22, 2019

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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