Skip to main content
OpenTrials
Completed

NCT Number: NCT02499276

Comparative Effects of Variable Pressure Support, NAVA and PAV

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Failure Pathological Conditions, Signs and Symptoms Patient-Ventilator Asynchrony Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Coefficient of variation of the tidal volume (VT)

    Time frame: 1 hour

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

  2. Coefficient of variation of the respiratory rate (RR)

    Time frame: 1 hour

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

  3. Coefficient of variation of the inspiratory time (Ti)

    Time frame: 1 hour

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

  4. 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)

  5. 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)

Secondary outcomes

  1. Patient ventilator asynchrony

    Time frame: 1 hour

    asynchrony index (composite outcome, that includes double triggering, auto triggering and ineffective efforts) )

  2. Safety from lung overdistension, assessed by the proportion of tidal volumes (VT) >10 ml/kg

    Time frame: 1 hour

  3. Gas exchanges

    Time frame: 6 hours

    Ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), arterial carbon dioxide pressure (PaCO2)

  4. Repartition of ventilation measured by electrical impedance tomography

    Time frame: 6 hours

  5. Dead space to tidal volume ratio (Vd/Vt)

    Time frame: 6 hours

    Vd/Vd, is a ratio between two volumes

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 16, 2015
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.