Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'

NCT02315937 | Suspended

• 1 other identifier: NL50108.060.14
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• vena cava inferior collapsibility (in %)

  vena cava inferior collapsibility: (Maximum vena cava inferior diameter - Minimum vena cava diameter)/maximum vena cava diameter

  1 hour

Interventions

transthoracic echocardiography PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients undergoing spinal anesthesia for minor surgery below the umbilicus

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (1)

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

MeSH Terms

Conditions

Hypotension; Hypovolemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arthur Bouwman, PhD

  Catharina Ziekenhuis Eindhoven

  STUDY DIRECTOR

• Harm Scholten, MD

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 12, 2014
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 26, 2016

Record last verified: 2016-07

Locations

NL (1)