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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02315937
Other study ID # NL50108.060.14
Secondary ID
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


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
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