Can Vena Cava Ultrasound Guided Volume Repletion Prevent Spinal Induced Significant Hypotension in Elective Patients?

August 1, 2017 updated by: Ente Ospedaliero Cantonale, Bellinzona

Can Vena Cava Ultrasound Guided Volume Repletion Prevent Spinal Induced Significant Hypotension in Elective Surgical Patients? A Randomized, Case Control, Prospective Trial.

Aim of this study is to determine whether Inferior Vena Cava analyzed by trans-thoracic echocardiography is an effective method to guide titrated fluid repletion in non critical patients, in order both to decrease post procedural significant hypotension rate and to avoid unnecessary fluid overload in patients undergoing spinal anesthesia for elective surgical procedures

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.

In addition to the current clinical standard, for the second arm of the study, a trans-thoracic echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Ospedale Regionale di Bellinzona e Valli (ORBV) - Sede Bellinzona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • both sexes
  • grater than 18 year old
  • requiring spinal anesthesia
  • classified according to American Society of Anesthesiology (ASA) level as 1, 2 or 3

Exclusion Criteria:

  • patients required invasive blood pressure monitoring (arterial/pulmonary catheter, thermodilution catheter),
  • patients show signs of pre-procedural hypotension (defined as two measurements of systolic arterial pressure less than 80 mmHg and/or mean arterial pressure less than 60 mmHg),
  • patients unable to give informed consent to language barriers, mental retard or any reduction in own ability to understand or give their informed consent,
  • patient in which is not possible to perform spinal anesthesia for patient's refusal or technical difficulties in sampling,
  • patients with International Normalized Ratio (INR) greater than 1.5 and/or activated Partial Thrombin Time in therapeutic range (more than 1.5 - 2 times the patient's normal values) and/or anti-factor X activity in therapeutic range
  • patients with thrombocytopenia less than 50 G/l.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Wild-Type
The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
Experimental: Echocardiography
In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.
Device: Ultrasound-guided volemic repletion
After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness, previously defined as a reduction of Inferior Vena Cava diameter less than 36% from baseline level during normal breath
Other Names:
  • IVCUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Arterial Hypotension
Time Frame: 30 minute after spinal anesthesia
To compare rates of arterial hypotension (previously define by international standard) after spinal anesthesia in patients who have undergone volemic optimization according to Trans-thoracic Echocardiography with patients who have been treated according to the current standard on the intention to treat population.
30 minute after spinal anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Amount of IV Fluid at the End of the Procedure
Time Frame: 30 minutes after spinal anesthesia
To assess if there is a difference between all treatments in the total quantity of fluids amount
30 minutes after spinal anesthesia
Percentage of Participants Administered Vasoactive Drug
Time Frame: 30 minutes after spinal anesthesia
Total amount of vasoactive drug administered for each group; for "vasoactive drug" we intended the use both of atropine than vascular amine
30 minutes after spinal anesthesia
Time of Procedures
Time Frame: From time 0 to 30 minutes after spinal anesthesia
Time employed to execute all procedure from the start of the study till 30 minutes after the end of the procedure
From time 0 to 30 minutes after spinal anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Investigators

  • Principal Investigator: Samuele Ceruti, MD, Ente Ospedaliero Cantonale, Bellinzona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 19, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERU-1402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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