Use of NAVA in Intubated Preterm

Phase 1

Withdrawn

• Conditions: Infant, Premature; Respiration, Artificial

• Registration Number: NCT00536445
• Lead Sponsor: Sunnybrook Health Sciences Centre

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-25
• Study First Submitted QC: 2007-09-26
• Study First Posted: 2007-09-27
• Study Start: 2007-10
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-30
• Last Update Posted: 2016-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Preterm newborn (>1 day postnatal age, gestational age >23 weeks, birth weight <1250g), intubated and mechanically ventilated, and 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: assist control/pressure support < 22 cm H2O, PEEP 4-6 cm H2O Fi02<.30

Exclusion Criteria

• Pneumothorax, degenerative neuromuscular disease, bleeding disorders, cardiovascular instability, cyanotic congenital cardiovascular disease, phrenic nerve damage/diaphragm paralysis, esophageal perforation, use of high frequency oscillatory or jet ventilation, contraindication to changing NG tube, or if infant is deemed "too unstable" by the clinical team. The use of narcotics is an exclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
• 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	end of the 12 hour trial

Secondary Outcome Measures

Name	Time	Method
• Number of times back-up rate started (per hour) • Number of PEEP or NAVA level adjustments	end of the 12 hour trial

Trial Locations

Locations (1)

NICU, Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada