Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03266250
Recruitment Status : Completed
First Posted : August 30, 2017
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Theodosis Saranteas, MD, National and Kapodistrian University of Athens

Brief 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.


Condition or disease Intervention/treatment
Spinal Anesthetic Toxicity Inferior Vena Cava Abnormality Intraoperative Complications Procedure: spinal anesthesia

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Transthoracic Echocardiography of Inferior Vena Cava Before Spinal Anesthesia Can Predict Hypotension in Elderly Orthopaedic Patients
Actual Study Start Date : August 15, 2017
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 20, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
spinal anesthesia Hypotensive patients
Transthoracic echocardiography of IVC before spinal anaesthesia
Procedure: spinal anesthesia
Transthoracic echocardiography of inferior vena cava before spinal anesthesia

spinal anesthesia Normotensive patients
Transthoracic echocardiography of IVC before spinal anaesthesia
Procedure: spinal anesthesia
Transthoracic echocardiography of inferior vena cava before spinal anesthesia




Primary Outcome Measures :
  1. Preoperative performance of the dIVCmax/IVCCI ratio [ Time Frame: 6 months ]
    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 Outcome Measures :
  1. Echocardiographic or clinical measurements [ Time Frame: 6 months ]
    To identify other echocardiographic or clinical measurements that can predict an intraoperative spinal-induced haemodynamic instability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Elderly orthopaedic patients
Criteria

Inclusion Criteria: patients with AHA/ACC stage I, II or III with their cardiac disease status in compensated status -

Exclusion Criteria: patients with AHA/ACC stage IV

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266250


Locations
Layout table for location information
Greece
ATTIKON University General Hospital
Athens, Attika, Greece, 15562
Sponsors and Collaborators
National and Kapodistrian University of Athens
Investigators
Layout table for investigator information
Principal Investigator: Theodosis Saranteas, MD National and Kapodistrian University of Athens, School of Medicine

Publications:
Layout table for additonal information
Responsible Party: Theodosis Saranteas, MD, Assistant Professor, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03266250     History of Changes
Other Study ID Numbers: ED399,09-24-2015
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Theodosis Saranteas, MD, National and Kapodistrian University of Athens:
inferior vena caca ultrasound
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension
Intraoperative Complications
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs