Use of Neurally Adjusted Ventilatory Assist in Infants Respiratory Failure (NAVA)
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.
|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|
- patient-ventilator synchrony [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]Patient-ventilator synchrony (trigger delays, cycling-off delays (Beck 2007))
- 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
|Study Start Date:||January 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00603174
|Research Center -CHU Sainte Justine - University of Montreal|
|Montreal, Quebec, Canada, H3T 1C5|
|Principal Investigator:||Philippe A Jouvet, MD||Université de Montréal|
|Principal Investigator:||Jennifer Beck, PhD||SunnyBrook Health Sciences Centre - Toronto|