Comparative Effects of Variable Pressure Support, NAVA and PAV

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Device: PSV, NAVA, PAV, Variable-PSV

• Registration Number: NCT02499276
• Lead Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Brief Summary

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

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

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-06-12
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PSV, PAV, NAVA, Variable-PSV	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.

Primary Outcome Measures

Name	Time	Method
Coefficient of variation of the tidal volume (VT)	1 hour	Coefficient of variation (standard deviation/mean) of the tidal volume (VT)
Coefficient of variation of the inspiratory time (Ti)	1 hour	Coefficient of variation (standard deviation/mean) of the inspiratory time (Ti)
Coefficient of variation of the maximal inspiratory pressure (Ppeak)	1 hour	Coefficient of variation (standard deviation/mean) of the maximal inspiratory pressure (Ppeak)
Coefficient of variation of the electrical activity of the diaphragm (EAdi)	1 hour	Coefficient of variation (standard deviation/mean) of the electrical activity of the diaphragm (EAdi)
Coefficient of variation of the respiratory rate (RR)	1 hour	Coefficient of variation (standard deviation/mean) of the respiratory rate (RR)

Secondary Outcome Measures

Name	Time	Method
Dead space to tidal volume ratio (Vd/Vt)	6 hours	Vd/Vd, is a ratio between two volumes
Safety from lung overdistension, assessed by the proportion of tidal volumes (VT) >10 ml/kg	1 hour
Gas exchanges	6 hours	Ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), arterial carbon dioxide pressure (PaCO2)
Repartition of ventilation measured by electrical impedance tomography	6 hours
Patient ventilator asynchrony	1 hour	asynchrony index (composite outcome, that includes double triggering, auto triggering and ineffective efforts) )

Trial Locations

Locations (1)

Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière; 🇫🇷 Paris, France