RecruitingACTRN12618000351213

Tidal Volume Challenge During Neurosurgery for Assessing Fluid Responsiveness. A Interventional Prospective Trial

Tidal Volume Challenge During Neurosurgery for Assessing Fluid Responsiveness. A Interventional Prospective Trial of Patients Scheduled for Supine Surgery


Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Enrollment

50 participants

Start Date

Jan 16, 2018

Study Type

Interventional

Conditions

Summary

TVC has never been tested in surgical populations. We aim to perform a clinical study to assess TVC reliability in supine surgical patients. The TVC has been proposed as novel hemodynamic test to assess fluid responsiveness in ICU patients. TVC consists in the transient increase of Tidal Volume from 6ml/kg to 8ml/kg for 1 minute. The TVC-related changes of stroke volume variation (SVV) and pulse pressure variation (PPV) are highly predictive of fluid responsiveness. The aim of the present study is to assess TVC reliability in a population of neurosurgical patients scheduled for supine surgery.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a bedside method called the Tidal Volume Challenge (TVC) to help doctors figure out whether a patient having brain surgery (neurosurgery) needs extra IV fluids during the operation. Getting fluid management right during surgery is important — too little or too much fluid can cause complications. The TVC involves briefly increasing the breathing rate of the patient's ventilator for one minute and measuring how the heart responds. This approach has been tested in ICU patients but never before in surgical patients. You may be eligible if: - You are 18 years or older - You are having planned (elective) neurosurgery and require direct blood pressure monitoring (arterial line) - Your anaesthesiologist has determined you need fluid during surgery You may NOT be eligible if: - You have any heart rhythm irregularity (arrhythmia) - You have unstable pressure in your brain (intracranial pressure) or are having emergency surgery - You have spinal shock - You have not given consent Talk to your doctor about whether this trial might be right for you.

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Interventions

The TVC has been proposed as novel hemodynamic test to assess fluid responsiveness in ICU patients. TVC consists in the transient increase of Tidal Volume from 6ml/kg to 8ml/kg for 1 minute. The TVC-r

The TVC has been proposed as novel hemodynamic test to assess fluid responsiveness in ICU patients. TVC consists in the transient increase of Tidal Volume from 6ml/kg to 8ml/kg for 1 minute. The TVC-related changes of stroke volume variation (SVV) and pulse pressure variation (PPV) are highly predictive of fluid responsiveness. The aim of the present study is to assess TVC reliability in a population of neurosurgical patients scheduled for supine surgery. Brief description of TVC: 1) TVC is a transient increase in the Tidal Volume used to ventilate the patient from 6 to 8 ml/kg of predicted body weight 2) The duration is 1 minute 3) The attending anesthetist will modify the setting of the ventilation in operating room 4) The decision of administer fluids because of transient hypotension (defined as a reduction of >20% of systolic blood pressure recorded at the beginning of the operation) is the indication to perform first the TVC 5) Only the first fluid challenge will be recorded. The frequency of administration will be decided by the attending anesthetist according to the occurrence of hemodynamic instability, for the entire duration of the operation. The end-expiratory occlusion test is a hemodynamic test aiming to assess fluid responsiveness by means of a interruption of mechanical ventilation. In order to compare TVC with EEO, the EEO will be also performed in all the patients at predefined time points (before and after TVC, when the patient is ventilated with 6ml/kg and 8 lm/kg respectively).


Locations(1)

Italy

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ACTRN12618000351213