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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02499276
Enrollment
12
Registered
2015-07-16
Start date
2015-05-31
Completion date
2015-12-31
Last updated
2015-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

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

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

Interventions

DEVICEPSV, NAVA, PAV, Variable-PSV

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

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Coefficient of variation of the maximal inspiratory pressure (Ppeak)1 hourCoefficient of variation (standard deviation/mean) of the maximal inspiratory pressure (Ppeak)
Coefficient of variation of the tidal volume (VT)1 hourCoefficient of variation (standard deviation/mean) of the tidal volume (VT)
Coefficient of variation of the respiratory rate (RR)1 hourCoefficient of variation (standard deviation/mean) of the respiratory rate (RR)
Coefficient of variation of the inspiratory time (Ti)1 hourCoefficient of variation (standard deviation/mean) of the inspiratory time (Ti)
Coefficient of variation of the electrical activity of the diaphragm (EAdi)1 hourCoefficient of variation (standard deviation/mean) of the electrical activity of the diaphragm (EAdi)

Secondary

MeasureTime frameDescription
Patient ventilator asynchrony1 hourasynchrony index (composite outcome, that includes double triggering, auto triggering and ineffective efforts) )
Safety from lung overdistension, assessed by the proportion of tidal volumes (VT) >10 ml/kg1 hour
Gas exchanges6 hoursRatio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), arterial carbon dioxide pressure (PaCO2)
Repartition of ventilation measured by electrical impedance tomography6 hours
Dead space to tidal volume ratio (Vd/Vt)6 hoursVd/Vd, is a ratio between two volumes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026