Use of NAVA in Intubated Preterm - Full Text View

Sponsored by:	Sunnybrook Health Sciences Centre
Information provided by:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00536445

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 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.

Condition	Intervention	Phase
Infant, Premature Respiration, Artificial	Device: NAVA	Phase I Phase II

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Use of Neurally Adjusted Ventilatory Assist (NAVA) in an Intubated Premature Infant: A Case Control Study on the Servoi Ventilator

Resource links provided by NLM:

MedlinePlus related topics: Critical Care Premature Babies

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:

• 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Number of times back-up rate started (per hour) • Number of PEEP or NAVA level adjustments [ Time Frame: end of the 12 hour trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	1
Study Start Date:	October 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Neurally Adjusted Ventilatory Assist (mechanical ventilation controlled by the diaphragm electrical activity)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536445

Contacts

Contact: Michael Dunn, MD	416-323-7312	michael.dunn@sunnybrook.ca
Contact: Maureen Reilly, RRT	416-323-6400 ext 4598	maureen.reilly@sunnybrook.ca

Locations

Canada, Ontario
NICU, Sunnybrook Health Sciences Centre	Recruiting
Toronto, Ontario, Canada, M5S1B6
Principal Investigator: Dunn Michael, MD
Principal Investigator: Jennifer Beck, PhD
Sub-Investigator: Maureen Reilly, RRT

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Investigators

Principal Investigator:	Michael Dunn, MD	Sunnybrook Health Sciences Centre
Principal Investigator:	Jennifer Beck, PhD	Sunnybrook Health Sciences Centre

More Information

Publications:

Beck J, Campoccia F, Allo JC, Brander L, Brunet F, Slutsky AS, Sinderby C. Improved synchrony and respiratory unloading by neurally adjusted ventilatory assist (NAVA) in lung-injured rabbits. Pediatr Res. 2007 Mar;61(3):289-94.

Responsible Party:	SHSC ( Dr Michael Dunn )
Study ID Numbers:	124-2007
Study First Received:	September 25, 2007
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00536445 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:

NAVA
Preterm
Case study

ClinicalTrials.gov processed this record on September 11, 2009