Mechanical Ventilation Complication, Respiratory Failure
Conditions
Keywords
Mechanical Ventilation, Non Invasive Ventilation, Weaning, Neurally Adjusted Ventilator Assist
Brief summary
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.
Detailed description
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.
Interventions
DEVICEnPSV and PSV
Ventilation with neurally adjusted modes or pressure support modes
Sponsors
ASL Novara
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
All the patients will be ventilated in both modes.
Intervention model description
Patients will be ventilated in nPSV or PSV (according to randomization) and then, after an initial period of ventilation, they will be ventilated with the other technique. Ventilation then will be optimized by an expert and the two modes of ventilation will be repeated in succession.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (\>18aa) * Non Invasive Ventilation with helmet * NG tubing for clinical use in position * Invasive arterial monitoring for clinical use in position
Exclusion criteria
* Unable to express consent * Expected NIV \< 24hrs * Gastric-esophageal surgery in the preceding 12 months * Upper-GI bleeding in the last 30 days * History of esophageal varices * Recent trauma or facial surgery * Haemodynamic instability even a after liquid infusion (need of at least dopamine \>5 γ/kg/min or norepinephrine \>0.1 γ/kg min to obtain systolic pressure \>90 mmHg) * Core temperature \>30 C° * Coagulation disorders (INR \> 1.5 and/or aPTT \>44 sec)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of synchrony in nPSV v.s PSV | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory rate | last 2 minutes over 30 minutes registration | Respiratory Rate (Breath per minute) |
| Inspiratory time | last 2 minutes over 30 minutes registration | Inspiratory Time \[Ti\] (s) |
| Neural Inspiratory Time | last 2 minutes over 30 minutes registration | Neural Inspiratory Time \[Tineu\] (s) |
| Inspiratory Neural-Ventilator Coupling | 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 |
| Peak of Electrical Activity of the diaphragm | last 2 minutes over 30 minutes registration | Peak of Electrical Activity of the diaphragm \[EAdi peak\] (mcV) |
| Asynchrony index | 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) |
| Tidal Volume | last 2 minutes over 30 minutes registration | Tidal Volume (ml) |
| Minute Volume | last 2 minutes over 30 minutes registration | Minute Volume Ventilation (L) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood gas analysis Carbon Dioxide level | At the end of each 30-minutes trial | Concentration of Arterial Carbon Dioxide Partial Pressure \[PaCO2\] (mmHg) |
| Blood gas analysis Bicarbonate level | At the end of each 30-minutes trial | Concentration of Sodium Bicarbonate \[HCO3-\] (mEq/L) |
| Blood gas analysis Lactate level | At the end of each 30-minutes trial | Concentration of Lactate \[Lac\] (mmol/L) |
| Blood gas analysis pH level | At the end of each 30-minutes trial | pH (-log10H+) |
| Blood gas analysis Oxygen level | At the end of each 30-minutes trial | Concentration of Arterial Oxygen Partial Pressure \[PaO2\] (mmHg) |
Countries
Italy
Outcome results
None listed