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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499860
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
Department of Anaesthesiology, Merano Hospital, Italy
Information provided by (Responsible Party):
Simon Rauch, Institute of Mountain Emergency Medicine

Study Description
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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).


Condition or disease Intervention/treatment Phase
Fluid Responsiveness Diagnostic Test: Passive Leg Raising Test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prediction of Fluid Responsiveness From Passive Leg Raising Induced Changes in Perfusion Index and Pleth Variability Index
Actual Study Start Date : April 20, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019
Arms and Interventions
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Intervention Details:
  • Diagnostic Test: Passive Leg Raising Test
    A passive leg raising test is performed in all patients included in the study

Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499860


Locations
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Italy
"F. Tappeiner" Hospital Merano
Merano, Bolzano, Italy, 39012
Sponsors and Collaborators
Institute of Mountain Emergency Medicine
Department of Anaesthesiology, Merano Hospital, Italy
More Information
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Responsible Party: Simon Rauch, Researcher, Institute of Mountain Emergency Medicine
ClinicalTrials.gov Identifier: NCT03499860    
Other Study ID Numbers: 06
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No