Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'

NCT ID: NCT02315937

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Hypotension; Hypovolemia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

transthoracic echocardiography

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

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Harm Scholten

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arthur Bouwman, PhD

Role: STUDY_DIRECTOR

Catharina Ziekenhuis Eindhoven

Harm Scholten, MD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

Other Identifiers

NL50108.060.14

Identifier Type: -

Identifier Source: org_study_id