Patient-ventilator Interaction During NIV With Helmet: a Comparison Between PSV and the New NIV NPS Software

ASL Novara

Status

Completed

Conditions

Respiratory Failure

Mechanical Ventilation Complication

Treatments

Device: nPSV and PSV

Study type

Interventional

Funder types

Other

Identifiers

NCT06004206

NiVnPSV

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)