SS. Trinità Hospital
Borgomanero, Novara, 28021, Italy
NCT Number: NCT06004206
The goal of this clinical trial is to evaluate if neural pressure support ventilation is able to improve patient-ventilator synchrony, in ICU patients undergoing non-invasive ventilation (NIV). The main question it aims to answer is:
• Is neural pressure support ventilation better than the pressure support ventilation with respect to patient-ventilator synchrony during helmet NIV?
Researchers will compare neural pressure support ventilation versus pressure support ventilation (Gold standard assisted mode in Europe) to see if the new mode improve patient-ventilator synchrony.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Borgomanero, Novara, 28021, Italy
Non-Invasive Ventilation (NIV) has found many different uses in clinical settings, shortening intubation times and preventing orotracheal intubation. NIV success is highly affected by patient comfort and patient-ventilator synchrony. The helmet is one of the most comfortable interfaces, even if synchrony is low due to dead space. The use of Neurally Adjusted Ventilatory Assist (NAVA), in which the Electrical Activity of the Diaphragm (EAdi) drives the ventilator, has shown improvement in comfort and synchrony but still some limitation with helmet, due to the long pressurization time. Pressure-Support Ventilation (PSV) is still the most used and diffused assisted mode in Europe due to its simplicity and effectiveness in helmet-NIV. The aim of this study is to test a new ventilation software called Neural Pressure Support Ventilation (nPSV), which merges the rapid pressurization of PSV along with the EAdi trigger, onto a population of 24 critical care patients ventilated with a helmet NIV.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ventilation with neurally adjusted modes or pressure support modes
Time frame: last 2 minutes over 30 minutes registration
Synchrony time [Timesych]: time frame during which both the ventilator and the neural patient inspiratory time are in the inspiratory phase (s)
Time frame: last 2 minutes over 30 minutes registration
Tidal Volume (ml)
Time frame: last 2 minutes over 30 minutes registration
Minute Volume Ventilation (L)
Time frame: last 2 minutes over 30 minutes registration
Respiratory Rate (Breath per minute)
Time frame: last 2 minutes over 30 minutes registration
Inspiratory Time [Ti] (s)
Time frame: last 2 minutes over 30 minutes registration
Neural Inspiratory Time [Tineu] (s)
Time frame: last 2 minutes over 30 minutes registration
Inspiratory Neural-Ventilator Coupling [NCVi] (Percentage): i.e. the time frame during which both the ventilator and the neural signal are into inspiratory phase
Time frame: last 2 minutes over 30 minutes registration
Peak of Electrical Activity of the diaphragm [EAdi peak] (mcV)
Time frame: last 2 minutes over 30 minutes registration
Asynchrony Index (AI): ratio between the number of ineffective efforts, auto-triggers and double triggers and the neural respiratory rate plus auto-triggers (percentage)
Time frame: At the end of each 30-minutes trial
pH (-log10H+)
Time frame: At the end of each 30-minutes trial
Concentration of Arterial Oxygen Partial Pressure [PaO2] (mmHg)
Time frame: At the end of each 30-minutes trial
Concentration of Arterial Carbon Dioxide Partial Pressure [PaCO2] (mmHg)
Time frame: At the end of each 30-minutes trial
Concentration of Sodium Bicarbonate [HCO3-] (mEq/L)
Time frame: At the end of each 30-minutes trial
Concentration of Lactate [Lac] (mmol/L)
ASL Novara
Other Gov
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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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