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Comparative Effects of Variable Pressure Support, NAVA and PAV

A

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

Status

Completed

Conditions

Respiratory Failure

Treatments

Device: PSV, NAVA, PAV, Variable-PSV

Study type

Interventional

Funder types

Other

Identifiers

NCT02499276
ADOREPS-2013-0802

Details and patient eligibility

About

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.

Full 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

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

PSV, PAV, NAVA, Variable-PSV
Experimental group
Description:
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.
Treatment:
Device: PSV, NAVA, PAV, Variable-PSV

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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