CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 429 enrolled
Drug / intervention
Trans-thoracic echocardiography +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02070276
NCT02070276N/ACompleted

Can Non Invasive Methods for Fluid Responsive Assessment Optimize Preventive Volemic Repletion in Order to Prevent Significant Hypotension After Spinal Anesthesia? A Randomized Trial

Ente Ospedaliero Cantonale, Bellinzona·interventional·Posted Feb 25, 2014·Updated Jul 13, 2020

In Brief

A clinical study evaluating Trans-thoracic echocardiography and Passive Leg Raising Test for Hypotension and Shock and Excessive Amount of Blood / Fluid Infusion. Completed, enrolled 429 participants across 1 site.

Detailed Summary

Spinal anesthesia is still the regional anesthesia technique most widely employed in everyday clinical practice. The most feared and common of its well known side effects consist in an abrupt reduction of systemic vascular resistances, with consequence risk of systemic hypotension. To prevent this potentially severe complication, an adequate correction of patients' volume status through a preventive administration of fluids is widely used. However this volume repletion is commonly accomplished on an empirical basis, without having a real insight of patient hemodynamic status, carrying the risk of possible volume overload. Aim of the study is to test the clinical impact of two simple, non-invasive methods to guide volemic repletion before spinal anesthesia on the reduction of significant hypotension rate, compared to empirical fluid administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSwitzerland
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2014
Enrollment StartMay 1, 2014
Primary CompletionFeb 1, 2019
Study CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.4 years ago

Interventions

Trans-thoracic echocardiographyprocedure

Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not.

Passive Leg Raising Testprocedure

Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia.