Skip to main content
Clinical Trials/NCT02315937
NCT02315937
Suspended
Not Applicable

Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'

Catharina Ziekenhuis Eindhoven1 site in 1 country35 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypotension
Sponsor
Catharina Ziekenhuis Eindhoven
Enrollment
35
Locations
1
Primary Endpoint
vena cava inferior collapsibility (in %)
Status
Suspended
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
December 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Catharina Ziekenhuis Eindhoven
Responsible Party
Principal Investigator
Principal Investigator

Harm Scholten

MD

Catharina Ziekenhuis Eindhoven

Eligibility Criteria

Inclusion Criteria

  • Adult age (\>18 years)
  • Written informed consent
  • Minor surgery under the umbilicus, e.g. herniorrhaphy, transurethral resection of bladder or prostate, orthopaedic procedures
  • ASA class I or II

Exclusion Criteria

  • No informed consent
  • ASA class III or higher
  • Obstetric surgery
  • Emergency procedures
  • Pre-existing neurological injury or disease
  • Contra-indications for spinal anesthesia (e.g. coagulation abnormalities)

Outcomes

Primary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials