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Use of Neurally Adjusted Ventilatory Assist in Infants Respiratory Failure

NCT00603174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-09-19

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 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Philippe A Jouvet, MD · Université de Montréal

  • Jennifer Beck, PhD · SunnyBrook Health Sciences Centre - Toronto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT00603174 on ClinicalTrials.gov