A Phase 1/2 interventional study of NAVA in Infant, Premature and Respiration, Artificial, sponsored by Sunnybrook Health Sciences Centre. Withdrawn at 1 site in Canada. Open to participants aged 1 Day and older. Per ClinicalTrials.gov, last updated 2016-06-01.
Sponsored by Sunnybrook Health Sciences Centre · Phase 1/2, Interventional, and Basic science
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 neonates 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 a premature baby on NAVA with the Servoi for 12 hours.
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Exclusion Criteria:
Neurally Adjusted Ventilatory Assist (mechanical ventilation controlled by the diaphragm electrical activity)
Also known as: Servoi (Maquet Critical Care AB)
• Patient-ventilator synchrony (trigger delays, cycling-off delays) • Phasic electrical activity of the diaphragm EAdi • Tonic EAdi • tidal volume, airway pressure, respiratory rate • Oxygen saturation, transcutaneous CO2, FIO2
Time frame: end of the 12 hour trial
• Number of times back-up rate started (per hour) • Number of PEEP or NAVA level adjustments
Time frame: end of the 12 hour trial
This study is withdrawn, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre