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Clinical Trials/NCT02315937
NCT02315937SuspendedNot Applicable

Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'

Catharina Ziekenhuis Eindhoven1 site in 1 country35 target enrollmentStarted: September 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Suspended
Sponsor
Enrollment
35
Locations
1
Primary Endpoint
vena cava inferior collapsibility (in %)

Study 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Catharina Ziekenhuis Eindhoven
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Harm Scholten

MD

Catharina Ziekenhuis Eindhoven

Study Sites (1)

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