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

NCT06004206 | Completed

• 1 other identifier: NiVnPSV
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Failure; Mechanical Ventilation Complication

Keywords

Mechanical Ventilation; Non Invasive Ventilation; Weaning; Neurally Adjusted Ventilator Assist

Outcome Measures

Primary Outcomes (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)

  last 2 minutes over 30 minutes registration

Secondary Outcomes (8)

• Tidal Volume

  last 2 minutes over 30 minutes registration

• Minute Volume

  last 2 minutes over 30 minutes registration

• Respiratory rate

  last 2 minutes over 30 minutes registration

• Inspiratory time

  last 2 minutes over 30 minutes registration

• Neural Inspiratory Time

  last 2 minutes over 30 minutes registration

Other Outcomes (5)

• Blood gas analysis pH level

  At the end of each 30-minutes trial

• Blood gas analysis Oxygen level

  At the end of each 30-minutes trial

• Blood gas analysis Carbon Dioxide level

  At the end of each 30-minutes trial

Study Arms (2)

nPSV first

EXPERIMENTAL

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

Device: nPSV and PSV

PSV first

EXPERIMENTAL

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

Device: nPSV and PSV

Interventions

nPSV and PSV DEVICE

Ventilation with neurally adjusted modes or pressure support modes

PSV first; nPSV first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• ASL Novara: lead

Study Sites (1)

SS. Trinità Hospital

Borgomanero, Novara, 28021, Italy

Location

Related Publications (7)

• 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.

  PMID: 11280630 RESULT

• 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.

  PMID: 15197438 RESULT

• 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.

  PMID: 19183949 RESULT

• 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.

  PMID: 17039354 RESULT

• 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.

  PMID: 18629471 RESULT

• 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.

  PMID: 25239821 RESULT

• 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.

  PMID: 38858795 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Davide Colombo, MD, PhD

  ASL Novara

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All the patients will be ventilated in both modes.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 22, 2023
• Study Start: October 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 15, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)