Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist

Not Applicable

• Conditions: Acute Respiratory Failure
• Interventions: Device: PSV mode; Device: PAV mode; Device: NAVA

• Registration Number: NCT02056093
• Lead Sponsor: Pierre and Marie Curie University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-12-18
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Study First Submitted QC: 2014-02-04
• Last Update Submitted: 2014-02-04
• Study First Posted: 2014-02-05
• Last Update Posted: 2014-02-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intubated patients	PSV mode	Intubated patients: The three modes (PSV, PAV, NAVA) will be applied in random order to each mechanically ventilated patient included in the study.
Intubated patients	PAV mode	Intubated patients: The three modes (PSV, PAV, NAVA) will be applied in random order to each mechanically ventilated patient included in the study.
Intubated patients	NAVA	Intubated patients: The three modes (PSV, PAV, NAVA) will be applied in random order to each mechanically ventilated patient included in the study.

Primary Outcome Measures

Name	Time	Method
Breathing pattern variability	February 2014	The coefficient of variation (standard deviation divided by the mean) of the tidal volume (expressed in %)

Secondary Outcome Measures

Name	Time	Method
Patient-ventilator asynchrony	February, 2014	Prevalence of ineffective efforts and double triggering (expressed as a number of events per minute)

Trial Locations

Locations (1)

Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie Salpetriere; 🇫🇷 Paris, Ile de France, France