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

September 20, 2012 updated by: University Hospital, Geneva

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • St Luc University hospital
      • Liege, Belgium
        • Bernard Lambermont
  • Switzerland
      • Geneva, Switzerland, 1211
        • HUG, University Hospital
      • Lausanne, Switzerland, 1011
        • CHUV University Hospital of Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pressure support
Non invasive ventilation under pressure support (PS)
Active Comparator: Neurally Adjusted Ventilatory Assist
Non invasive ventilation under Neurally Adjusted ventilatory Assist
Device: Neurally Adjusted Ventilatory Assist
Non invasive ventilation under Neurally adjusted Ventilatory Assist
Other Names:
  • NAVA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient-ventilator synchronization parameters

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

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

Investigators

  • Study Director: Didier Tassaux, MD, HUG, University hospital Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 23, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

September 21, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NAVA_NIV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Invasive Ventilation

Clinical Trials on Neurally Adjusted Ventilatory Assist

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe