Use of NAVA in Intubated Preterm

NCT00536445 | Withdrawn Phase 1

• 1 other identifier: 124-2007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature; Respiration, Artificial

Keywords

NAVA; Preterm; Case study

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (1)

• • Number of times back-up rate started (per hour) • Number of PEEP or NAVA level adjustments

  end of the 12 hour trial

Interventions

NAVA DEVICE

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

Also known as: Servoi (Maquet Critical Care AB)

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

NICU, Sunnybrook Health Sciences Centre

Toronto, Ontario, M5S1B6, Canada

Location

Related Publications (1)

• 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. doi: 10.1203/01.pdr.0000257324.22406.93.

  PMID: 17314685 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Dunn, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Jennifer Beck, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 25, 2007
• First Posted: September 27, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

CA (1)