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Use of NAVA in Intubated Preterm

Primary Purpose

Infant, Premature, Respiration, Artificial

Status
Withdrawn
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
NAVA
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infant, Premature focused on measuring NAVA, Preterm, Case study

Eligibility Criteria

1 Day - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NICU, Sunnybrook Health Sciences Centre

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2007
Last Updated
May 30, 2016
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00536445
Brief Title
Use of NAVA in Intubated Preterm
Official Title
Use of Neurally Adjusted Ventilatory Assist (NAVA) in an Intubated Premature Infant: A Case Control Study on the Servoi Ventilator
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Another institution performed the study
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Respiration, Artificial
Keywords
NAVA, Preterm, Case study

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
NAVA
Other Intervention Name(s)
Servoi (Maquet Critical Care AB)
Intervention Description
Neurally Adjusted Ventilatory Assist (mechanical ventilation controlled by the diaphragm electrical activity)
Primary Outcome Measure Information:
Title
• 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
Secondary Outcome Measure Information:
Title
• Number of times back-up rate started (per hour) • Number of PEEP or NAVA level adjustments
Time Frame
end of the 12 hour trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dunn, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Beck, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
NICU, Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S1B6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17314685
Citation
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.
Results Reference
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Use of NAVA in Intubated Preterm

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