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Sponsors and Collaborators: |
University of Montreal Sunnybrook Health Sciences Centre |
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Information provided by: | University of Montreal |
ClinicalTrials.gov Identifier: | NCT00603174 |
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 |
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Respiratory Failure |
Device: neurally adjusted ventilatory assist (NAVA) |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Use of Neurally Adjusted Ventilatory Assist in Infants With Acute Respiratory Failure: a Case Study on Servo I |
Estimated Enrollment: | 5 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Intubated and mechanically ventilated infants with respiratory failure (age < 1 year old)
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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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Ages Eligible for Study: | up to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Philippe A Jouvet, MD | + 1 514 345 4931 ext 4927 | philippe.jouvet@umontreal.ca |
Contact: Jennifer Beck, PhD | jennifer.beck@rogers.com |
Canada, Quebec | |
Research Center -CHU Sainte Justine - University of Montreal | Recruiting |
Montreal, Quebec, Canada, H3T 1C5 | |
Principal Investigator: Philippe A Jouvet, MD |
Principal Investigator: | Philippe A Jouvet, MD | University of Montreal |
Principal Investigator: | Jennifer Beck, PhD | SunnyBrook Health Sciences Centre - Toronto |
Responsible Party: | University of Montreal ( P Jouvet MD ) |
Study ID Numbers: | HSJ 2537 |
Study First Received: | November 21, 2007 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00603174 |
Health Authority: | Canada: Health Canada |
NAVA mechanical ventilation infants pediatric intensive care infant |
Respiratory Insufficiency Respiratory Tract Diseases Respiration Disorders |