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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSV, PAV, NAVA, Variable-PSV | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSV, NAVA, PAV, Variable-PSV | Device | Each patient enrolled in the study will be ventilated in all the following modes: PSV, NAVA, PAV and variable PSV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of variation of the tidal volume (VT) | Coefficient of variation (standard deviation/mean) of the tidal volume (VT) | 1 hour |
| Coefficient of variation of the respiratory rate (RR) | Coefficient of variation (standard deviation/mean) of the respiratory rate (RR) | 1 hour |
| Coefficient of variation of the inspiratory time (Ti) | Coefficient of variation (standard deviation/mean) of the inspiratory time (Ti) | 1 hour |
| Coefficient of variation of the electrical activity of the diaphragm (EAdi) | Coefficient of variation (standard deviation/mean) of the electrical activity of the diaphragm (EAdi) | 1 hour |
| Coefficient of variation of the maximal inspiratory pressure (Ppeak) | Coefficient of variation (standard deviation/mean) of the maximal inspiratory pressure (Ppeak) | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Patient ventilator asynchrony | asynchrony index (composite outcome, that includes double triggering, auto triggering and ineffective efforts) ) | 1 hour |
| Safety from lung overdistension, assessed by the proportion of tidal volumes (VT) >10 ml/kg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Demoule, MD, PHD | Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D000097742 | Patient-Ventilator Asynchrony |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| 1 hour |
| Gas exchanges | Ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), arterial carbon dioxide pressure (PaCO2) | 6 hours |
| Repartition of ventilation measured by electrical impedance tomography | 6 hours |
| Dead space to tidal volume ratio (Vd/Vt) | Vd/Vd, is a ratio between two volumes | 6 hours |
| D013568 | Pathological Conditions, Signs and Symptoms |