MedTrace Logo

Transthoracic Echocardiography of Inferior Vena Cava Before Spinal Anesthesia Can Predict Hypotension

NCT03266250 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2018-08-21

No results posted yet for this study

Summary

Study Protocol: Outcome Measurements Primary Outcome The main outcome will be the preoperative performance of the dIVCmax/IVCCI ratio to foresee the incidence of hypotension after spinal anesthesia in a greater extent to that of the established IVCCI measurements.

Secondary Outcomes To identify other echocardiographic or clinical measurements that can predict an intraoperative spinal-induced haemodynamic instability.

Sample Size Calculation A pilot study of 20 patients revealed a detected area under the ROC curve (AUC) of 0,91 for dIVCmax/IVCCI and for dIVCmax 0,82 with rank correlation between the two assays being 0.87 in both positive and negative cases. Based on this result, a sample of 56 patients will achieve 80% power to detect significant difference (at a level 0.05) between dIVCmax/IVCCI and dIVCmax.

Potential Benefits of the Study The results of this study will allow us to determine which clinical or US-measurement can yield better performance so as a preoperative prediction of spinal-induced hypotension can be achieved; that way these measurements can permit and guide a targeted preoperative fluid challenges prior to the implementation of spinal anesthesia Potential Side Effects of the Study Participation in this protocol will not put patients at higher risk for complications since we do not perform any intervention (either pharmacological or surgical) There will be no occupational risks to researchers or assistants. Proposed Timetable According to the exclusion criteria and taking into account the number of cases performed in our department per monthly basis, it should take us approximately 6 months to recruit 60 patients.

Conditions

  • Spinal Anesthetic Toxicity
  • Inferior Vena Cava Abnormality
  • Intraoperative Complications

Interventions

PROCEDURE

spinal anesthesia

Transthoracic echocardiography of inferior vena cava before spinal anesthesia

Sponsors & Collaborators

  • National and Kapodistrian University of Athens

    lead OTHER

Principal Investigators

  • Theodosis Saranteas, MD · National and Kapodistrian University of Athens, School of Medicine

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-15
Primary Completion
2018-07-20
Completion
2018-07-20

Countries

  • Greece

Study Locations

More Related Trials

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 NCT03266250 on ClinicalTrials.gov