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

July 18, 2019 updated by: Simon Rauch, Institute of Mountain Emergency Medicine

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bolzano
      • Merano, Bolzano, Italy, 39012
        • "F. Tappeiner" Hospital Merano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 seconds
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
90 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Mountain Emergency Medicine

Collaborators

Department of Anaesthesiology, Merano Hospital, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2018

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

March 31, 2018

First Submitted That Met QC Criteria

April 13, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fluid Responsiveness

Clinical Trials on Passive Leg Raising Test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe