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

Sponsor

ASL Novara (Other)

Overall Status

Completed

CT.gov ID

NCT06004206

Collaborator

(none)

Enrollment

Location

Arms

32.4

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure Mechanical Ventilation Complication	Device: nPSV and PSV	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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)

Masking Description:

All the patients will be ventilated in both modes.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Jun 1, 2023

Actual Study Completion Date :

Jun 15, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Improvement of synchrony in nPSV v.s PSV [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 Outcome Measures

Respiratory pattern in nPSV vs PSV [last 2 minutes over 30 minutes registration]
Tidal Volume (ml)
Respiratory pattern in nPSV vs PSV [last 2 minutes over 30 minutes registration]
Minute Volume Ventilation (L)
Respiratory pattern in nPSV vs PSV [last 2 minutes over 30 minutes registration]
Respiratory Rate (Breath per minute)
Respiratory pattern in nPSV vs PSV [last 2 minutes over 30 minutes registration]
Inspiratory Time [Ti] (s)
Respiratory pattern in nPSV vs PSV [last 2 minutes over 30 minutes registration]
Neural Inspiratory Time [Tineu] (s)
Patient Ventilator Synchrony in nPSV vs PSV [last 2 minutes over 30 minutes registration]
Inspiratory Neural-Ventilator Coupling [NCVi] (Percentage)
Respiratory pattern in nPSV vs PSV [last 2 minutes over 30 minutes registration]
Peak of Electrical Activity of the diaphragm [EAdi peak] (mcV)
Patient Ventilator Synchrony in nPSV vs PSV [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Haemodinamic instability even a after liquid infusion (need of at least dopamine >5 γ/kg/min or norephinephrine >0.1 γ/kg min to obtain systolic pressure >90 mmHg)
Core temperature >30C°
Coagulation disorders (INR > 1.5 and/or aPTT >44 sec)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SS. Trinità Hospital	Borgomanero	Novara	Italy	28021

Sponsors and Collaborators

ASL Novara

Investigators

Study Chair: Davide Colombo, MD, PhD, ASL Novara

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Davide Colombo, Doctor, ASL Novara

ClinicalTrials.gov Identifier:

NCT06004206

Other Study ID Numbers:

NiVnPSV

First Posted:

Aug 22, 2023

Last Update Posted:

Aug 22, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Davide Colombo, Doctor, ASL Novara

Mechanical Ventilation

Non Invasive Ventilation

Weaning

Neurally Adjusted Ventilator Assist

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of Aug 22, 2023