Comparative Effects of Variable Pressure Support, Neurally Adjusted Ventilatory Assist (NAVA) and Proportional Assist Ventilation (PAV) on the Variability of the Breathing Pattern and on Patient Ventilator Interaction
| Registry | NCT02499276 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 12 (Actual) |
| Sponsor | Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil (Other) |
| Conditions | Respiratory Failure |
| Interventions | PSV, NAVA, PAV, Variable-PSV (Device) |
| Dates | start 2015-05-01, primary completion 2015-12-01, completion 2015-12-01, first posted 2015-07-16, last updated 2015-12-29 |
| Locations | 1 site in France |
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All trials for Respiratory Failure All trials of PSV, NAVA, PAV, Variable-PSV
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.
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PSV, PAV, NAVA, Variable-PSV | Experimental | Device: PSV, NAVA, PAV, 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. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière | Paris | France |