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

This study has been completed.
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Philippe Jouvet, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT00603174
First received: November 21, 2007
Last updated: September 18, 2012
Last verified: September 2012
  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)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • patient-ventilator synchrony [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    Patient-ventilator synchrony (trigger delays, cycling-off delays (Beck 2007))


Secondary Outcome Measures:
  • Tolerance [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    Evolution of tidal volume, airway pressure, respiratory rate, SAO2, End Tidal PCO2, FIO2

  • Number of times back-up rate started (per hour) in NAVA mode [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • Number of PEEP or NAVA level adjustments in NAVA mode [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • Phasic EAdi • Tonic EAdi Phasic EAdi and tonic EAdi [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    Phasic EAdi and tonic EAdi compared between pressure support, pressure control and NAVA modes


Enrollment: 10
Study Start Date: January 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603174

Locations
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
Investigators
Principal Investigator: Philippe A Jouvet, MD Université de Montréal
Principal Investigator: Jennifer Beck, PhD SunnyBrook Health Sciences Centre - Toronto
  More Information

Publications:
Responsible Party: Philippe Jouvet, Associate Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT00603174     History of Changes
Other Study ID Numbers: HSJ 2537
Study First Received: November 21, 2007
Last Updated: September 18, 2012
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
NAVA
mechanical ventilation
infants
pediatric intensive care
infant

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

ClinicalTrials.gov processed this record on July 20, 2014