Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'

Hypotension Clinical Trial

— SATE  

Official title:

Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02315937
• Other study ID #: NL50108.060.14
• Status: Suspended
• Phase: N/A
• First received: December 8, 2014
• Last updated: July 25, 2016
• Start date: September 2016
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 35
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypotension
• Hypovolemia

Intervention

Procedure:
• transthoracic echocardiography
measurement of inferior vena cava diameter during inspiration and expiration using transthoracic echocardiography

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vena cava inferior collapsibility (in %)	vena cava inferior collapsibility: (Maximum vena cava inferior diameter - Minimum vena cava diameter)/maximum vena cava diameter	1 hour	No