Use of Neurally Adjusted Ventilatory Assist in Infants Respiratory Failure (NAVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00603174
Recruitment Status : Completed
First Posted : January 28, 2008
Last Update Posted : September 19, 2012
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Philippe Jouvet, St. Justine's Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Respiratory Failure Device: neurally adjusted ventilatory assist (NAVA) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Neurally Adjusted Ventilatory Assist in Infants With Acute Respiratory Failure: a Case Study on Servo I
Study Start Date : January 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
Intubated and mechanically ventilated infants with respiratory failure (age < 1 year old). see inclusion-exclusion criteria.
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.

Primary Outcome Measures :
  1. patient-ventilator synchrony [ Time Frame: up to 28 days ]
    Patient-ventilator synchrony (trigger delays, cycling-off delays (Beck 2007))

Secondary Outcome Measures :
  1. Tolerance [ Time Frame: up to 28 days ]
    Evolution of tidal volume, airway pressure, respiratory rate, SAO2, End Tidal PCO2, FIO2

  2. Number of times back-up rate started (per hour) in NAVA mode [ Time Frame: up to 28 days ]
  3. Number of PEEP or NAVA level adjustments in NAVA mode [ Time Frame: up to 28 days ]
  4. Phasic EAdi • Tonic EAdi Phasic EAdi and tonic EAdi [ Time Frame: up to 28 days ]
    Phasic EAdi and tonic EAdi compared between pressure support, pressure control and NAVA modes

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00603174

Canada, Quebec
Research Center -CHU Sainte Justine - University of Montreal
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
St. Justine's Hospital
Sunnybrook Health Sciences Centre
Principal Investigator: Philippe A Jouvet, MD Université de Montréal
Principal Investigator: Jennifer Beck, PhD SunnyBrook Health Sciences Centre - Toronto

Responsible Party: Philippe Jouvet, Associate Professor, St. Justine's Hospital Identifier: NCT00603174     History of Changes
Other Study ID Numbers: HSJ 2537
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: September 19, 2012
Last Verified: September 2012

Keywords provided by Philippe Jouvet, St. Justine's Hospital:
mechanical ventilation
pediatric intensive care

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases