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Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography' (SATE)

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ClinicalTrials.gov Identifier: NCT02315937
Recruitment Status : Suspended (logistic reasons; amendment pending with IRB)
First Posted : December 12, 2014
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Harm Scholten, Catharina Ziekenhuis Eindhoven

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.


Condition or disease Intervention/treatment
Hypotension Hypovolemia Procedure: transthoracic echocardiography

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'
Study Start Date : September 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients undergoing spinal anesthesia for minor surgery below the umbilicus
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315937


Locations
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Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Investigators
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Study Director: Arthur Bouwman, PhD Catharina Ziekenhuis Eindhoven
Principal Investigator: Harm Scholten, MD Catharina Ziekenhuis Eindhoven

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Responsible Party: Harm Scholten, MD, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT02315937     History of Changes
Other Study ID Numbers: NL50108.060.14
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Hypotension
Hypovolemia
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes