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Comparison of Pressure-, Flow- and Neurally Adjusted Ventilatory Assistance (NAVA)-Triggering in Pediatric and Neonatal Ventilatory Care

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ClinicalTrials.gov Identifier: NCT00893087
Recruitment Status : Completed
First Posted : May 5, 2009
Last Update Posted : January 20, 2010
Sponsor:
Collaborator:
University of Tampere
Information provided by:
University of Oulu

May 3, 2009
May 5, 2009
January 20, 2010
February 2009
July 2009   (Final data collection date for primary outcome measure)
The time in ventilator-patient synchrony in each of the assist modes. [ Time Frame: 30 min ]
Same as current
Complete list of historical versions of study NCT00893087 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Pressure-, Flow- and Neurally Adjusted Ventilatory Assistance (NAVA)-Triggering in Pediatric and Neonatal Ventilatory Care
Comparison of Pressure-, Flow- and NAVA-triggering in Pediatric and Neonatal Ventilatory Care

The purpose of this study is to study whether neurally adjusted ventilatory assist (NAVA) provides advantages over current methods in detecting patients own breathing efforts in pediatric and neonatal ventilatory care.

Our study hypothesis is that NAVA-technology is more accurate than currently used methods in detecting and assisting spontaneous breathing in children, and thus the patient-ventilator synchrony will improve.

Asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications, make the weaning more difficult and may affect the survival rates.

In this study we will compare two currently used methods pressure- and flow-triggering with a neurally adjusted ventilatory assist in synchronization of the ventilator support with patients own efforts.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Respiration
  • Device: Triggering mode of the ventilator
    10 min of each triggering mode
  • Device: Triggering method of the ventilator
    Flow triggering
  • Device: Triggering method of the ventilator
    Pressure triggering
  • Device: Triggering method of the ventilator
    NAVA triggering
  • Active Comparator: 1
    Flow triggering
    Interventions:
    • Device: Triggering mode of the ventilator
    • Device: Triggering method of the ventilator
  • Active Comparator: 2
    Pressure triggering
    Interventions:
    • Device: Triggering mode of the ventilator
    • Device: Triggering method of the ventilator
  • Active Comparator: 3
    NAVA triggering
    Interventions:
    • Device: Triggering mode of the ventilator
    • Device: Triggering method of the ventilator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
Same as current
August 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All children born over 30 weeks of gestation needing ventilatory care

Exclusion Criteria:

  • Craniofacial malformation which does not allow feeding tobe positioning. Critical ventilatory or perfusion problems.
Sexes Eligible for Study: All
up to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT00893087
EETTMK:122/2008
No
Not Provided
Not Provided
Tero Kontiokari, MD, PhD, Associate Professor, University of Oulu
University of Oulu
University of Tampere
Not Provided
University of Oulu
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP