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Completed

NCT Number: NCT06004206

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SS. Trinità Hospital

Borgomanero, Novara, 28021, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

nPSV and PSV

Device

Ventilation with neurally adjusted modes or pressure support modes

Primary outcomes

  1. Improvement of synchrony in nPSV v.s PSV

    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)

Secondary outcomes

  1. Tidal Volume

    Time frame: last 2 minutes over 30 minutes registration

    Tidal Volume (ml)

  2. Minute Volume

    Time frame: last 2 minutes over 30 minutes registration

    Minute Volume Ventilation (L)

  3. Respiratory rate

    Time frame: last 2 minutes over 30 minutes registration

    Respiratory Rate (Breath per minute)

  4. Inspiratory time

    Time frame: last 2 minutes over 30 minutes registration

    Inspiratory Time [Ti] (s)

  5. Neural Inspiratory Time

    Time frame: last 2 minutes over 30 minutes registration

    Neural Inspiratory Time [Tineu] (s)

  6. Inspiratory Neural-Ventilator Coupling

    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

  7. Peak of Electrical Activity of the diaphragm

    Time frame: last 2 minutes over 30 minutes registration

    Peak of Electrical Activity of the diaphragm [EAdi peak] (mcV)

  8. Asynchrony index

    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)

Other outcomes

  1. Blood gas analysis pH level

    Time frame: At the end of each 30-minutes trial

    pH (-log10H+)

  2. Blood gas analysis Oxygen level

    Time frame: At the end of each 30-minutes trial

    Concentration of Arterial Oxygen Partial Pressure [PaO2] (mmHg)

  3. Blood gas analysis Carbon Dioxide level

    Time frame: At the end of each 30-minutes trial

    Concentration of Arterial Carbon Dioxide Partial Pressure [PaCO2] (mmHg)

  4. Blood gas analysis Bicarbonate level

    Time frame: At the end of each 30-minutes trial

    Concentration of Sodium Bicarbonate [HCO3-] (mEq/L)

  5. Blood gas analysis Lactate level

    Time frame: At the end of each 30-minutes trial

    Concentration of Lactate [Lac] (mmol/L)

Sponsors and collaborators

Lead sponsor

ASL Novara

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2023
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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