Comparative Effects of Variable Pressure Support, NAVA and PAV

Respiratory Failure Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499276
• Other study ID #: ADOREPS-2013-0802
• Status: Completed
• Phase: N/A
• First received: June 12, 2015
• Last updated: December 28, 2015
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière	Paris

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coefficient of variation of the tidal volume (VT)	Coefficient of variation (standard deviation/mean) of the tidal volume (VT)	1 hour	No
Primary	Coefficient of variation of the respiratory rate (RR)	Coefficient of variation (standard deviation/mean) of the respiratory rate (RR)	1 hour	Yes
Primary	Coefficient of variation of the inspiratory time (Ti)	Coefficient of variation (standard deviation/mean) of the inspiratory time (Ti)	1 hour	No
Primary	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	No
Primary	Coefficient of variation of the maximal inspiratory pressure (Ppeak)	Coefficient of variation (standard deviation/mean) of the maximal inspiratory pressure (Ppeak)	1 hour	No
Secondary	Patient ventilator asynchrony	asynchrony index (composite outcome, that includes double triggering, auto triggering and ineffective efforts) )	1 hour	No
Secondary	Safety from lung overdistension, assessed by the proportion of tidal volumes (VT) >10 ml/kg		1 hour	Yes
Secondary	Gas exchanges	Ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), arterial carbon dioxide pressure (PaCO2)	6 hours	No
Secondary	Repartition of ventilation measured by electrical impedance tomography		6 hours	No
Secondary	Dead space to tidal volume ratio (Vd/Vt)	Vd/Vd, is a ratio between two volumes	6 hours	No