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

Not Applicable

Completed

• Conditions: Respiratory Failure; Mechanical Ventilation Complication
• Interventions: Device: nPSV and PSV

• Registration Number: NCT06004206
• Lead Sponsor: ASL Novara

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.

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-15
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
nPSV first	nPSV and PSV	Patients will follow the pattern: nPSV -\> PSV -\> nPSVo -\> PSVo
PSV first	nPSV and PSV	Patients will follow the pattern: PSV -\> nPSV -\> PSVo -\> nPSVo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Peak of Electrical Activity of the diaphragm	last 2 minutes over 30 minutes registration	Peak of Electrical Activity of the diaphragm \[EAdi peak\] (mcV)
Minute Volume	last 2 minutes over 30 minutes registration	Minute Volume Ventilation (L)
Tidal Volume	last 2 minutes over 30 minutes registration	Tidal Volume (ml)
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
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)

Trial Locations

Locations (1)

SS. Trinità Hospital; 🇮🇹 Borgomanero, Novara, Italy