Clinical trial NCT02499276: Comparative Effects of Variable Pressure Support, NAVA and PAV
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: mechanical ventilation
pressure support ventilation
NAVA
PAV
variable ventilation
patient ventilator asynchrony
Lead sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Coefficient of variation of the tidal volume (VT)
timeFrame: 1 hour
measure: Coefficient of variation of the respiratory rate (RR)
timeFrame: 1 hour
measure: Coefficient of variation of the inspiratory time (Ti)
timeFrame: 1 hour
measure: Coefficient of variation of the electrical activity of the diaphragm (EAdi)
timeFrame: 1 hour
measure: Coefficient of variation of the maximal inspiratory pressure (Ppeak)
timeFrame: 1 hour
Secondary outcomes:
measure: Patient ventilator asynchrony
timeFrame: 1 hour
measure: Safety from lung overdistension, assessed by the proportion of tidal volumes (VT) >10 ml/kg
timeFrame: 1 hour
measure: Gas exchanges
timeFrame: 6 hours
measure: Repartition of ventilation measured by electrical impedance tomography
timeFrame: 6 hours
measure: Dead space to tidal volume ratio (Vd/Vt)
timeFrame: 6 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière
Study officials:
affiliation: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
name: Alexandre Demoule, MD, PHD
role: STUDY_DIRECTOR
References: