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Clinical Trials/NCT02499276
NCT02499276
Completed
Not Applicable

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

Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil1 site in 1 country12 target enrollmentMay 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Enrollment
12
Locations
1
Primary Endpoint
Coefficient of variation of the tidal volume (VT)
Status
Completed
Last Updated
10 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Coefficient of variation of the tidal volume (VT)

Time Frame: 1 hour

Coefficient of variation (standard deviation/mean) of the tidal volume (VT)

Coefficient of variation of the inspiratory time (Ti)

Time Frame: 1 hour

Coefficient of variation (standard deviation/mean) of the inspiratory time (Ti)

Coefficient of variation of the maximal inspiratory pressure (Ppeak)

Time Frame: 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)

Time Frame: 1 hour

Coefficient of variation (standard deviation/mean) of the electrical activity of the diaphragm (EAdi)

Coefficient of variation of the respiratory rate (RR)

Time Frame: 1 hour

Coefficient of variation (standard deviation/mean) of the respiratory rate (RR)

Secondary Outcomes

  • Dead space to tidal volume ratio (Vd/Vt)(6 hours)
  • Safety from lung overdistension, assessed by the proportion of tidal volumes (VT) >10 ml/kg(1 hour)
  • Gas exchanges(6 hours)
  • Repartition of ventilation measured by electrical impedance tomography(6 hours)
  • Patient ventilator asynchrony(1 hour)

Study Sites (1)

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