Comparative Effects of Variable Pressure Support, NAVA and PAV

NCT02499276 | Completed DMC

• 1 other identifier: ADOREPS-2013-0802
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Keywords

mechanical ventilation; pressure support ventilation; NAVA; PAV; variable ventilation; patient ventilator asynchrony

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Patient ventilator asynchrony

  1 hour

• 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

• Dead space to tidal volume ratio (Vd/Vt)

  6 hours

Study Arms (1)

PSV, PAV, NAVA, Variable-PSV

EXPERIMENTAL

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

Interventions

PSV, NAVA, PAV, Variable-PSV DEVICE

Each patient enrolled in the study will be ventilated in all the following modes: PSV, NAVA, PAV and variable PSV

PSV, PAV, NAVA, Variable-PSV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient on mechanical ventilation for \>48 h
• estimated duration of mechanical ventilation \>24h
• hemodynamic stability

You may not qualify if:

• pregnancy
• impossibility to insert an EAdi catheter
• neuromuscular disease, phrenic nerve lesions

Sponsors & Collaborators

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

Study Sites (1)

Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Patient-Ventilator Asynchrony

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandre Demoule, MD, PHD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: July 16, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-07

Locations

FR (1)