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Use of NAVA in Intubated Preterm

NCT00536445 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2016-06-01

No results posted yet for this study

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

Interventions

DEVICE

NAVA

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

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Michael Dunn, MD · Sunnybrook Health Sciences Centre

  • Jennifer Beck, PhD · Sunnybrook Health Sciences Centre

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536445 on ClinicalTrials.gov