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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03499860
Enrollment
51
Registered
2018-04-17
Start date
2018-04-20
Completion date
2019-04-01
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Responsiveness

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).

Interventions

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

Sponsors

Department of Anaesthesiology, Merano Hospital, Italy
CollaboratorUNKNOWN
Institute of Mountain Emergency Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PI difference90 secondsDifference in the change of perfusion index from baseline during a passive leg raising maneuver in fluid responsive patients compared to fluid non-responders
PVI difference90 secondsDifference in the change of pleth variability index from baseline during a passive leg raising maneuver in fluid responsive patients compared to fluid non-responders

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026