Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist

Acute Respiratory Failure Clinical Trial

— PAVANAVA  

Official title:

Breathing Pattern Variability, Respiratory Discomfort and Work of Breathing in Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02056093
• Other study ID #: ADOREP
• Status: Recruiting
• Phase: N/A
• First received: December 18, 2013
• Last updated: February 4, 2014
• Start date: September 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Pierre and Marie Curie University
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

In spontaneously breathing mechanically ventilated patients, the adequacy between the patient's demand and the level of respiratory support delivered by the ventilator is a major clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist ventilation (PAV) have been developed to adapt the level of assistance to the patient's demand. These two modes have been compared to pressure support ventilation (PSV) but have not been compared to each other.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Intubated patients.

• Mechanical ventilation for a respiratory reason.

• Expected duration of Mechanical ventilation > 48 hrs.

• Spontaneous breathing.

• Sedations stopped for more than 24 hours.

Exclusion Criteria:

• - Main contra indications to NAVA: gastro-oesophageal surgery in the previous 12 months, oesophageal obstruction, gastro-esophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma or surgery, neuromuscular diseases, individuals with known or suspected phrenic nerve dysfunction.

• Main contra indications to PAV: airway leak, body weight <25 kg, neuromuscular diseases.

• Hemodynamic instability defined as the current administration of vasopressors or inotropic drugs.

• Severe hypoxemia defined as PaO2/FiO2 ratio <200.

• Decision to withhold life-sustaining treatment.

• Pregnant women.

• Minors < 18 years.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• PSV mode
Application of PSV in all patients
• PAV mode
Application of PAV mode in all patients
• NAVA

Locations

Country	Name	City	State
France	Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie Salpetriere	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Pierre and Marie Curie University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Electrical diaphragm activity Gas exchange	measured by the NAVA probe	February 2014	No
Primary	Breathing pattern variability	The coefficient of variation (standard deviation divided by the mean) of the tidal volume (expressed in %)	February 2014	No
Secondary	Patient-ventilator asynchrony	Prevalence of ineffective efforts and double triggering (expressed as a number of events per minute)	February, 2014	No