AzTrials
AzTrials

Respiratory FailureNCT06004206

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

A study testing nPSV and PSV in people with Respiratory Failure and Mechanical Ventilation Complication, run by ASL Novara at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
nPSV and PSV
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteItaly
Study dates
1 Oct 2020to 15 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients (>18aa)
  • Non Invasive Ventilation with helmet
  • NG tubing for clinical use in position
  • Invasive arterial monitoring for clinical use in position

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • SS. Trinità Hospital

    Borgomanero, Novara, 28021

Other trials in Italy

About this study

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.

Read the 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.

Being tested
nPSV and PSV
Keywords
Mechanical Ventilation, Non Invasive Ventilation, Weaning, Neurally Adjusted Ventilator Assist
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nPSV and PSVDevice

    Ventilation with neurally adjusted modes or pressure support modes

Study groups in NCT06004206
Study groupRoleWhat they receive
nPSV firstExperimentalPatients will follow the pattern: nPSV -> PSV -> nPSVo -> PSVo
Receives: Device: nPSV and PSV
PSV firstExperimentalPatients will follow the pattern: PSV -> nPSV -> PSVo -> nPSVo
Receives: Device: nPSV and PSV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: last 2 minutes over 30 minutes registration

Secondary outcomes (8)

  1. Tidal Volume

    Tidal Volume (ml)

    Measured: last 2 minutes over 30 minutes registration

  2. Minute Volume

    Minute Volume Ventilation (L)

    Measured: last 2 minutes over 30 minutes registration

  3. Respiratory rate

    Respiratory Rate (Breath per minute)

    Measured: last 2 minutes over 30 minutes registration

  4. Inspiratory time

    Inspiratory Time [Ti] (s)

    Measured: last 2 minutes over 30 minutes registration

  5. Neural Inspiratory Time

    Neural Inspiratory Time [Tineu] (s)

    Measured: last 2 minutes over 30 minutes registration

  6. 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

    Measured: last 2 minutes over 30 minutes registration

  7. Peak of Electrical Activity of the diaphragm

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

    Measured: last 2 minutes over 30 minutes registration

  8. 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)

    Measured: last 2 minutes over 30 minutes registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study start1 Oct 2020
  3. Primary completion1 Jun 2023
  4. Study completion15 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06004206
Sponsor's protocol ID
NiVnPSV
Status last verified
Jan 2024
First submitted
9 Aug 2023
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11280630

  • 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.

    PubMed 15197438

  • 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.

    PubMed 19183949

  • 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.

    PubMed 17039354

  • 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.

    PubMed 18629471

  • 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.

    PubMed 25239821

  • Costa A, Merlo F, Pagni A, Navalesi P, Grasselli G, Cammarota G, Colombo D. The new neural pressure support (NPS) mode and the helmet: did we find the dynamic duo? J Anesth Analg Crit Care. 2024 Jun 10;4(1):35. doi: 10.1186/s44158-024-00170-6.

    PubMed 38858795

Questions about this trial

What is this clinical trial studying?

A study testing nPSV and PSV in people with Respiratory Failure and Mechanical Ventilation Complication, run by ASL Novara at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of synchrony in nPSV v.s PSV (time frame: last 2 minutes over 30 minutes registration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06004206, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in