Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography' (SATE)
|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: NCT02315937|
Recruitment Status : Suspended (logistic reasons; amendment pending with IRB)
First Posted : December 12, 2014
Last Update Posted : July 26, 2016
Rationale: Spinal anesthesia is a safe, frequently used anesthetic technique. The main side effect of spinal anesthesia is hypotension, occuring in up to 85 % of selected cases. This hypotension is often treated with fluid infusion. However, especially in elderly patients, high volume fluid infusion can lead to fluid overload.
The effects of spinal anesthesia on preload and fluid responsiveness are not exactly known. Hence, therapy for hypotension after spinal anesthesia might not be adequate. With transthoracic echocardiography, vena cava inferior diameter and collapsibility can be used to monitor fluid responsiveness and guide fluid management.
Objective: This study has two main objectives. The first is to explore the effects of spinal anesthesia on hemodynamic parameters of fluid status, especially vena cava inferior diameter and collapsibility. The second goal is to test the interrater variability transthoracic echocardiography exams when performed by (trained) anesthesiologists.
Furthermore, the correlation between vena cava inferior collapsibility and the occurence and degree of hypotension (defined as a decrease from baseline of >20% or a systolic pressure < 90 mmHg) after spinal anesthesia will be explored.
|Condition or disease||Intervention/treatment|
|Hypotension Hypovolemia||Procedure: transthoracic echocardiography|
|Study Type :||Observational|
|Estimated Enrollment :||35 participants|
|Official Title:||Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2016|
- Procedure: transthoracic echocardiography
measurement of inferior vena cava diameter during inspiration and expiration using transthoracic echocardiography
- vena cava inferior collapsibility (in %) [ Time Frame: 1 hour ]vena cava inferior collapsibility: (Maximum vena cava inferior diameter - Minimum vena cava diameter)/maximum vena cava diameter
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): NCT02315937
|Catharina Ziekenhuis Eindhoven|
|Eindhoven, Noord-Brabant, Netherlands, 5623 EJ|
|Study Director:||Arthur Bouwman, PhD||Catharina Ziekenhuis Eindhoven|
|Principal Investigator:||Harm Scholten, MD||Catharina Ziekenhuis Eindhoven|