Comparative Effects of Variable Pressure Support, NAVA and PAV

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Device: PSV, NAVA, PAV, Variable-PSV

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
• Investigators: Study Director: Alexandre Demoule, MD, PHD, Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Estimate): December 29, 2015
• Last Update Submitted That Met QC Criteria: December 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: mechanical ventilation; NAVA; pressure support ventilation; PAV; variable ventilation; patient ventilator asynchrony
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: ADOREPS-2013-0802