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Comparative Effects of Variable Pressure Support, NAVA and PAV

NCT ID: NCT02499276

Last Updated: 2015-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-12-31

Brief Summary

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Experimental animal data suggest that increasing breathing pattern variability in mechanical ventilation could be beneficial. Variable ventilation can be induced through the following modes: Neurally Adjust Ventilatory Assist (NAVA), Proportional Assist Ventilation (PAV) and Variable-Pressure Support Ventilation (V-PSV). These modes have not yet been compared to each other. Pilot observations in our department suggest a feasibility in patients.

The objectives of the study are to compare the impact of PSV, NAVA, PAV and V-PSV on the variability of the breathing pattern, patient-ventilator asynchrony, risk of lung overdistension, gas exchange, and repartition of ventilation.

Detailed Description

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Cross-over, prospective, randomized controlled monocentric trial . Patients on pressure support ventilation will be ventilated with PSV, NAVA, PAV, and V-PSV (in a randomized sequence).

In each mode the level of assistance will be set to achieve a similar tidal volume of 6-8 ml/kg.

The following data will be measured and recorded: airway flow and pressure, electrical activity of the diaphragm (EAdi), blood gases, electrical impedance tomography, end tidal partial pressure in carbon dioxide (PEtCO2).

Will be calculated: the coefficient of variation (CV, standard deviation (SD)/mean) of the peak pressure (Ppeak), EAdi and of the main descriptors of the breathing pattern, the prevalence of the main patient-ventilator asynchronies, the prevalence of tidal volume (VT) \>10ml/kg, ventrodorsal repartition of ventilation and inhomogeneity index, dead space

Conditions

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Respiratory Failure

Keywords

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mechanical ventilation pressure support ventilation NAVA PAV variable ventilation patient ventilator asynchrony

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PSV, PAV, NAVA, Variable-PSV

This is a crossover study in which each patient will be ventilated in the following modes of mechanical ventilation: Pressure Support Ventilation (PSV), Neurally Adjusted Ventilator Assist (NAVA), Proportional assist ventilation (NAVA) and variable Pressure Support Ventilation (Variable-PSV), in a randomised order.

Group Type EXPERIMENTAL

PSV, NAVA, PAV, Variable-PSV

Intervention Type DEVICE

Each patient enrolled in the study will be ventilated in all the following modes: PSV, NAVA, PAV and variable PSV

Interventions

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PSV, NAVA, PAV, Variable-PSV

Each patient enrolled in the study will be ventilated in all the following modes: PSV, NAVA, PAV and variable PSV

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patient on mechanical ventilation for \>48 h
* estimated duration of mechanical ventilation \>24h
* hemodynamic stability

Exclusion Criteria

* pregnancy
* impossibility to insert an EAdi catheter
* neuromuscular disease, phrenic nerve lesions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre Demoule, MD, PHD

Role: STUDY_DIRECTOR

Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Locations

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Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière

Paris, , France

Site Status

Countries

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France

Other Identifiers

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ADOREPS-2013-0802

Identifier Type: -

Identifier Source: org_study_id