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NCT03499860 Clinical Trial

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

Fluid Responsiveness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03499860
Other study ID # 06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2018
Est. completion date April 1, 2019

Study information
Verified date July 2019
Source Institute of Mountain Emergency Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Passive Leg Raising Test
A passive leg raising test is performed in all patients included in the study

Locations
Country Name City State
Italy "F. Tappeiner" Hospital Merano Merano Bolzano

Sponsors (2)
Lead Sponsor Collaborator
Institute of Mountain Emergency Medicine Department of Anaesthesiology, Merano Hospital, Italy

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary PI difference 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
Primary PVI difference 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
See also
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Withdrawn NCT01898975 - A Gray Zone Approach to Stroke Volume Variation Derived From NICOM N/A