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NCT Number: NCT02271477

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

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

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Key information

Conditions

Fluid Overload Anesthesia; Adverse Effect, Spinal and Epidural Edema Pathological Conditions, Signs and Symptoms Regional Anesthesia Morbidity Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Regionale di Bellinzona e Valli (ORBV) - Sede Bellinzona

Bellinzona, 6500, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound-guided volemic repletion

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 22, 2014
Registry last updated
Aug 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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