Neurally Adjusted Ventilatory Assist for Non Invasive Ventilation and Patient-ventilator Interaction

Non Invasive Ventilation Clinical Trial

Official title:

The Effects of Neurally Adjusted Ventilatory Assist (NAVA) on Improving Patient-ventilator Interaction in Patients Undergoing Ventilation for Acute Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074866
• Other study ID #: NAVA_NIV
• Status: Completed
• Phase: N/A
• First received: February 23, 2010
• Last updated: September 20, 2012
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2010
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin.

Description:

The present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin. The subgroup of COPD patients will be analyzed separately. The effects of various setting of Neurally adjusted ventilatory assist on patient-ventilator interaction will also be explored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients admitted to the ICU and treated with Non invasive ventilation for acute respiratory failure of any origin

Exclusion Criteria:

• severe hypoxemia requiring an FIO2>0.6

• hemodynamic instability

• known oesophageal problem

• active upper gastro-intestinal bleeding

• any other contraindication to the insertion of a naso-gastric tube

• impaired consciousness or absence of patient cooperation

• facial or laryngeal lesions contraindicating the use of NIV

• poor short term prognosis

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Non Invasive Ventilation
• Patient Ventilator Interaction

Intervention

Device:
• Neurally Adjusted Ventilatory Assist
Non invasive ventilation under Neurally adjusted Ventilatory Assist

Locations

Country	Name	City	State
Belgium	St Luc University hospital	Brussels
Belgium	Bernard Lambermont	Liege
Switzerland	HUG, University Hospital	Geneva
Switzerland	CHUV University hospital of Lausanne	Lausanne

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Geneva	Notre Dame de Grace Hospital, Gosselies, University Hospital Sart Tilman, Liege, University Hospital St Luc, Brussels, University of Lausanne Hospitals

Countries where clinical trial is conducted

Belgium,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-ventilator synchronization parameters			No