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

This study has been completed.
Sponsor:
Collaborator:
University of Tampere
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT00893087
First received: May 3, 2009
Last updated: January 19, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Respiration
Device: Triggering mode of the ventilator
Device: Triggering method of the ventilator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Pressure-, Flow- and NAVA-triggering in Pediatric and Neonatal Ventilatory Care

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • The time in ventilator-patient synchrony in each of the assist modes. [ Time Frame: 30 min ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Flow triggering
Device: Triggering mode of the ventilator
10 min of each triggering mode
Device: Triggering method of the ventilator
Flow triggering
Active Comparator: 2
Pressure triggering
Device: Triggering mode of the ventilator
10 min of each triggering mode
Device: Triggering method of the ventilator
Pressure triggering
Active Comparator: 3
NAVA triggering
Device: Triggering mode of the ventilator
10 min of each triggering mode
Device: Triggering method of the ventilator
NAVA triggering

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893087

Locations
Finland
University Hospital of Oulu
Oulu, Finland, 90220
Sponsors and Collaborators
University of Oulu
University of Tampere
  More Information

No publications provided

Responsible Party: Tero Kontiokari, MD, PhD, Associate Professor, University of Oulu
ClinicalTrials.gov Identifier: NCT00893087     History of Changes
Other Study ID Numbers: EETTMK:122/2008
Study First Received: May 3, 2009
Last Updated: January 19, 2010
Health Authority: Finland: Finnish Medicines Agency
Finland: Ministry of Social Affairs and Health
European Union: European Medicines Agency

Keywords provided by University of Oulu:
Ventilatory care, children, intensive care, asynchrony, triggering
Children needing ventilatory care

ClinicalTrials.gov processed this record on September 16, 2014