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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06004206
• Other study ID #: NiVnPSV
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 15, 2023

Study information

• Verified date: January 2024
• Source: ASL Novara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 15, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?/kg/min or norepinephrine >0.1 ?/kg min to obtain systolic pressure >90 mmHg)

• Core temperature >30 C°

• Coagulation disorders (INR > 1.5 and/or aPTT >44 sec)

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• nPSV and PSV
Ventilation with neurally adjusted modes or pressure support modes

Locations

Country	Name	City	State
Italy	SS. Trinità Hospital	Borgomanero	Novara

Sponsors (1)

Lead Sponsor	Collaborator
ASL Novara

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Colombo D, Cammarota G, Bergamaschi V, De Lucia M, Corte FD, Navalesi P. Physiologic response to varying levels of pressure support and neurally adjusted ventilatory assist in patients with acute respiratory failure. Intensive Care Med. 2008 Nov;34(11):20 — View Citation

Evans TW. International Consensus Conferences in Intensive Care Medicine: non-invasive positive pressure ventilation in acute respiratory failure. Organised jointly by the American Thoracic Society, the European Respiratory Society, the European Society o — View Citation

Muttini S, Villani PG, Trimarco R, Bellani G, Grasselli G, Patroniti N. Relation between peak and integral of the diaphragm electromyographic activity at different levels of support during weaning from mechanical ventilation: a physiologic study. J Crit C — View Citation

Navalesi P, Costa R, Ceriana P, Carlucci A, Prinianakis G, Antonelli M, Conti G, Nava S. Non-invasive ventilation in chronic obstructive pulmonary disease patients: helmet versus facial mask. Intensive Care Med. 2007 Jan;33(1):74-81. doi: 10.1007/s00134-0 — View Citation

Squadrone E, Frigerio P, Fogliati C, Gregoretti C, Conti G, Antonelli M, Costa R, Baiardi P, Navalesi P. Noninvasive vs invasive ventilation in COPD patients with severe acute respiratory failure deemed to require ventilatory assistance. Intensive Care Me — View Citation

Vignaux L, Vargas F, Roeseler J, Tassaux D, Thille AW, Kossowsky MP, Brochard L, Jolliet P. Patient-ventilator asynchrony during non-invasive ventilation for acute respiratory failure: a multicenter study. Intensive Care Med. 2009 May;35(5):840-6. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood gas analysis pH level	pH (-log10H+)	At the end of each 30-minutes trial
Other	Blood gas analysis Oxygen level	Concentration of Arterial Oxygen Partial Pressure [PaO2] (mmHg)	At the end of each 30-minutes trial
Other	Blood gas analysis Carbon Dioxide level	Concentration of Arterial Carbon Dioxide Partial Pressure [PaCO2] (mmHg)	At the end of each 30-minutes trial
Other	Blood gas analysis Bicarbonate level	Concentration of Sodium Bicarbonate [HCO3-] (mEq/L)	At the end of each 30-minutes trial
Other	Blood gas analysis Lactate level	Concentration of Lactate [Lac] (mmol/L)	At the end of each 30-minutes trial
Primary	Improvement of synchrony in nPSV v.s PSV	Synchrony time [Timesych]: time frame during which both the ventilator and the neural patient inspiratory time are in the inspiratory phase (s)	last 2 minutes over 30 minutes registration
Secondary	Tidal Volume	Tidal Volume (ml)	last 2 minutes over 30 minutes registration
Secondary	Minute Volume	Minute Volume Ventilation (L)	last 2 minutes over 30 minutes registration
Secondary	Respiratory rate	Respiratory Rate (Breath per minute)	last 2 minutes over 30 minutes registration
Secondary	Inspiratory time	Inspiratory Time [Ti] (s)	last 2 minutes over 30 minutes registration
Secondary	Neural Inspiratory Time	Neural Inspiratory Time [Tineu] (s)	last 2 minutes over 30 minutes registration
Secondary	Inspiratory Neural-Ventilator Coupling	Inspiratory Neural-Ventilator Coupling [NCVi] (Percentage): i.e. the time frame during which both the ventilator and the neural signal are into inspiratory phase	last 2 minutes over 30 minutes registration
Secondary	Peak of Electrical Activity of the diaphragm	Peak of Electrical Activity of the diaphragm [EAdi peak] (mcV)	last 2 minutes over 30 minutes registration
Secondary	Asynchrony index	Asynchrony Index (AI): ratio between the number of ineffective efforts, auto-triggers and double triggers and the neural respiratory rate plus auto-triggers (percentage)	last 2 minutes over 30 minutes registration