Comparative Effects of Variable Pressure Support, NAVA and PAV
Primary Purpose
Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PSV, NAVA, PAV, Variable-PSV
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure focused on measuring mechanical ventilation, pressure support ventilation, NAVA, PAV, variable ventilation, patient ventilator asynchrony
Eligibility Criteria
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
Sites / Locations
- Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PSV, PAV, NAVA, Variable-PSV
Arm 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.
Outcomes
Primary Outcome Measures
Coefficient of variation of the tidal volume (VT)
Coefficient of variation (standard deviation/mean) of the tidal volume (VT)
Coefficient of variation of the respiratory rate (RR)
Coefficient of variation (standard deviation/mean) of the respiratory rate (RR)
Coefficient of variation of the inspiratory time (Ti)
Coefficient of variation (standard deviation/mean) of the inspiratory time (Ti)
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)
Coefficient of variation of the maximal inspiratory pressure (Ppeak)
Coefficient of variation (standard deviation/mean) of the maximal inspiratory pressure (Ppeak)
Secondary Outcome Measures
Patient ventilator asynchrony
asynchrony 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/kg
Gas exchanges
Ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), arterial carbon dioxide pressure (PaCO2)
Repartition of ventilation measured by electrical impedance tomography
Dead space to tidal volume ratio (Vd/Vt)
Vd/Vd, is a ratio between two volumes
Full Information
NCT ID
NCT02499276
First Posted
June 12, 2015
Last Updated
December 28, 2015
Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
1. Study Identification
Unique Protocol Identification Number
NCT02499276
Brief Title
Comparative Effects of Variable Pressure Support, NAVA and PAV
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
mechanical ventilation, pressure support ventilation, NAVA, PAV, variable ventilation, patient ventilator asynchrony
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PSV, PAV, NAVA, Variable-PSV
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
PSV, NAVA, PAV, Variable-PSV
Intervention Description
Each patient enrolled in the study will be ventilated in all the following modes: PSV, NAVA, PAV and variable PSV
Primary Outcome Measure Information:
Title
Coefficient of variation of the tidal volume (VT)
Description
Coefficient of variation (standard deviation/mean) of the tidal volume (VT)
Time Frame
1 hour
Title
Coefficient of variation of the respiratory rate (RR)
Description
Coefficient of variation (standard deviation/mean) of the respiratory rate (RR)
Time Frame
1 hour
Title
Coefficient of variation of the inspiratory time (Ti)
Description
Coefficient of variation (standard deviation/mean) of the inspiratory time (Ti)
Time Frame
1 hour
Title
Coefficient of variation of the electrical activity of the diaphragm (EAdi)
Description
Coefficient of variation (standard deviation/mean) of the electrical activity of the diaphragm (EAdi)
Time Frame
1 hour
Title
Coefficient of variation of the maximal inspiratory pressure (Ppeak)
Description
Coefficient of variation (standard deviation/mean) of the maximal inspiratory pressure (Ppeak)
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Patient ventilator asynchrony
Description
asynchrony index (composite outcome, that includes double triggering, auto triggering and ineffective efforts) )
Time Frame
1 hour
Title
Safety from lung overdistension, assessed by the proportion of tidal volumes (VT) >10 ml/kg
Time Frame
1 hour
Title
Gas exchanges
Description
Ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), arterial carbon dioxide pressure (PaCO2)
Time Frame
6 hours
Title
Repartition of ventilation measured by electrical impedance tomography
Time Frame
6 hours
Title
Dead space to tidal volume ratio (Vd/Vt)
Description
Vd/Vd, is a ratio between two volumes
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Demoule, MD, PHD
Organizational Affiliation
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Official's Role
Study Director
Facility Information:
Facility Name
Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
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Comparative Effects of Variable Pressure Support, NAVA and PAV
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