NCT01074866

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 21, 2012

Status Verified

January 1, 2010

Enrollment Period

5 months

First QC Date

February 23, 2010

Last Update Submit

September 20, 2012

Conditions

Non Invasive VentilationPatient Ventilator Interaction

Keywords

Mechanical ventilationNon invasive VentilationPatient-ventilator interactionPressure supportNeurally adjusted ventilatory assist

Outcome Measures

Primary Outcomes (1)

  • Patient-ventilator synchronization parameters

Study Arms (2)

Pressure support

NO INTERVENTION

Non invasive ventilation under pressure support (PS)

Neurally Adjusted Ventilatory Assist

ACTIVE COMPARATOR

Non invasive ventilation under Neurally Adjusted ventilatory Assist

Device: Neurally Adjusted Ventilatory Assist

Interventions

Neurally Adjusted Ventilatory AssistDEVICE

Non invasive ventilation under Neurally adjusted Ventilatory Assist

Also known as: NAVA
Neurally Adjusted Ventilatory Assist

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St Luc University hospital

Brussels, Belgium

Location

Bernard Lambermont

Liège, Belgium

Location

HUG, University Hospital

Geneva, 1211, Switzerland

Location

CHUV University hospital of Lausanne

Lausanne, 1011, Switzerland

Location

MeSH Terms

Interventions

Interactive Ventilatory Support

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Didier Tassaux, MD

    HUG, University hospital Geneva

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 24, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

September 21, 2012

Record last verified: 2010-01

Locations

BE(2)CH(2)