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Predict Fluid Responsiveness in Spinal Anesthesia

NCT02070276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 429

Last updated 2020-07-13

Study results available
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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.

Conditions

  • Hypotension and Shock
  • Excessive Amount of Blood / Fluid Infusion

Interventions

PROCEDURE

Trans-thoracic echocardiography

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.

PROCEDURE

Passive Leg Raising Test

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

Sponsors & Collaborators

  • Ente Ospedaliero Cantonale, Bellinzona

    lead OTHER

Principal Investigators

  • Samuele Ceruti, MD · Ente Ospedaliero Cantonale - Ospedale Regionale di Bellinzona

  • Andrea Saporito, MD · Ente Ospedaliero Cantonale - Ospedale Regionale di Bellinzona

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2019-02-28
Completion
2019-08-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02070276 on ClinicalTrials.gov