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Use of Neurally Adjusted Ventilatory Assist in Infants Respiratory Failure (NAVA)
This study is currently recruiting participants.
Verified by University of Montreal, May 2008
Sponsors and Collaborators: University of Montreal
Sunnybrook Health Sciences Centre
Information provided by: University of Montreal
ClinicalTrials.gov Identifier: NCT00603174
  Purpose

The present protocol will demonstrate the feasibility and efficacy of a newly developed mode of mechanical ventilation, Neurally Adjusted Ventilatory Assist, commonly known as NAVA. During NAVA, the timing and magnitude of pressure delivered are controlled by the infants' diaphragm electrical activity (EAdi), a validated measurement of neural respiratory drive. Recent clinical trials in adults and term infants have shown that NAVA is more synchronous than conventional pressure support ventilation, and that NAVA delivers lower mean airway pressures to achieve the same ventilation and respiratory muscle unloading. NAVA has recently been approved for use in infants by Health Canada and the FDA in the United States, and is commercially available on the Servoi ventilator (Maquet Critical Care, Solna, Sweden). The present protocol is designed as a "case study" where the researchers responsible would like to evaluate the feasibility and efficacy of ventilating an infant on NAVA with the Servoi for 12 hours, and to compare it to conventional ventilation.


Condition Intervention
Respiratory Failure
Device: neurally adjusted ventilatory assist (NAVA)

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment
Official Title: Use of Neurally Adjusted Ventilatory Assist in Infants With Acute Respiratory Failure: a Case Study on Servo I

Further study details as provided by University of Montreal:

Primary Outcome Measures:
  • patient-ventilator synchrony [ Time Frame: prospective ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: January 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Intubated and mechanically ventilated infants with respiratory failure (age < 1 year old)
Device: neurally adjusted ventilatory assist (NAVA)
Following the titration of PEEP and the NAVA level, the infant will be ventilated on NAVA with the titrated levels. The following will be monitored and recorded for 20 min at 1 hour intervals: Phasic EAdi, tonic EAdi, tidal volume, ventilator-delivered pressure, respiratory rate, oxygen saturation, end tidal PCO2, and heart rate.

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  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intubated and mechanically ventilated infant with respiratory failure < 1 year old)
  • Breathing spontaneously, as defined by the ability to trigger the ventilator
  • The infant should be breathing on conventional ventilation (SIMV, assist control, or pressure support) with the following ventilator parameters: pressure plateau < 22 cm H2O (above PEEP) and PEEP ≤ 6 cm H2O.

Exclusion Criteria:

  • Pneumothorax
  • Degenerative neuromuscular disease
  • Bleeding disorders
  • Cardiovascular instability defined by vasopressors infusion (dopamine ≥ 5µg/kg/min, epinephrine, norepinephrine, dobutamine, vasopressin)
  • Cyanotic congenital cardiovascular disease
  • Phrenic nerve damage/diaphragm paralysis
  • Esophageal perforation
  • Use of high frequency oscillatory or jet ventilation
  • Contraindication to changing naso gastric tube
  • Infant is deemed "too unstable" by the attending physician
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603174

Contacts
Contact: Philippe A Jouvet, MD + 1 514 345 4931 ext 4927 philippe.jouvet@umontreal.ca
Contact: Jennifer Beck, PhD jennifer.beck@rogers.com

Locations
Canada, Quebec
Research Center -CHU Sainte Justine - University of Montreal Recruiting
Montreal, Quebec, Canada, H3T 1C5
Principal Investigator: Philippe A Jouvet, MD            
Sponsors and Collaborators
University of Montreal
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Philippe A Jouvet, MD University of Montreal
Principal Investigator: Jennifer Beck, PhD SunnyBrook Health Sciences Centre - Toronto
  More Information

Publications:
Responsible Party: University of Montreal ( P Jouvet MD )
Study ID Numbers: HSJ 2537
Study First Received: November 21, 2007
Last Updated: August 13, 2008
ClinicalTrials.gov Identifier: NCT00603174  
Health Authority: Canada: Health Canada

Keywords provided by University of Montreal:
NAVA
mechanical ventilation
infants
pediatric intensive care
infant

Study placed in the following topic categories:
Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on January 14, 2009