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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Mechanical Ventilation Complication
• Intervention / Treatment: Device: nPSV and PSV

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Novara
    • Borgomanero, Novara, Italy, 28021
      • SS. Trinità Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nPSV first; Patients will follow the pattern: nPSV -> PSV -> nPSVo -> PSVo	Device: nPSV and PSV; Ventilation with neurally adjusted modes or pressure support modes
Experimental: PSV first; Patients will follow the pattern: PSV -> nPSV -> PSVo -> nPSVo	Device: nPSV and PSV; Ventilation with neurally adjusted modes or pressure support modes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal Volume	Tidal Volume (ml)	last 2 minutes over 30 minutes registration
Minute Volume	Minute Volume Ventilation (L)	last 2 minutes over 30 minutes registration
Respiratory rate	Respiratory Rate (Breath per minute)	last 2 minutes over 30 minutes registration
Inspiratory time	Inspiratory Time [Ti] (s)	last 2 minutes over 30 minutes registration
Neural Inspiratory Time	Neural Inspiratory Time [Tineu] (s)	last 2 minutes over 30 minutes registration
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
Peak of Electrical Activity of the diaphragm	Peak of Electrical Activity of the diaphragm [EAdi peak] (mcV)	last 2 minutes over 30 minutes registration
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood gas analysis pH level	pH (-log10H+)	At the end of each 30-minutes trial
Blood gas analysis Oxygen level	Concentration of Arterial Oxygen Partial Pressure [PaO2] (mmHg)	At the end of each 30-minutes trial
Blood gas analysis Carbon Dioxide level	Concentration of Arterial Carbon Dioxide Partial Pressure [PaCO2] (mmHg)	At the end of each 30-minutes trial
Blood gas analysis Bicarbonate level	Concentration of Sodium Bicarbonate [HCO3-] (mEq/L)	At the end of each 30-minutes trial
Blood gas analysis Lactate level	Concentration of Lactate [Lac] (mmol/L)	At the end of each 30-minutes trial

Collaborators and Investigators

• Sponsor: ASL Novara
• Investigators: Study Chair: Davide Colombo, MD, PhD, ASL Novara

Publications and helpful links

General Publications

• 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: 10.1007/s00134-009-1416-5. Epub 2009 Jan 29.
• 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 of Intensive Care Medicine, and the Societe de Reanimation de Langue Francaise, and approved by the ATS Board of Directors, December 2000. Intensive Care Med. 2001 Jan;27(1):166-78. doi: 10.1007/s001340000721. No abstract available.
• 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 Med. 2004 Jul;30(7):1303-10. doi: 10.1007/s00134-004-2320-7. Epub 2004 Jun 12.
• 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/s00134-006-0391-3. Epub 2006 Oct 13.
• 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):2010-8. doi: 10.1007/s00134-008-1208-3. Epub 2008 Jul 16.
• 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 Care. 2015 Feb;30(1):7-12. doi: 10.1016/j.jcrc.2014.08.013. Epub 2014 Aug 28.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Weaning; Mechanical Ventilation; Non Invasive Ventilation; Neurally Adjusted Ventilator Assist
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: NiVnPSV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No