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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-06-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Respiratory Failure Mechanical Ventilation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

All the patients will be ventilated in both modes.

Study Groups

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nPSV first

Patients will follow the pattern: nPSV -\> PSV -\> nPSVo -\> PSVo

Group Type EXPERIMENTAL

nPSV and PSV

Intervention Type DEVICE

Ventilation with neurally adjusted modes or pressure support modes

PSV first

Patients will follow the pattern: PSV -\> nPSV -\> PSVo -\> nPSVo

Group Type EXPERIMENTAL

nPSV and PSV

Intervention Type DEVICE

Ventilation with neurally adjusted modes or pressure support modes

Interventions

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nPSV and PSV

Ventilation with neurally adjusted modes or pressure support modes

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No