Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merja Ålander, University of Oulu
ClinicalTrials.gov Identifier:
NCT01056939
First received: January 19, 2010
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to find out if NAVA-technology is better in detecting patients own inspiratory efforts during mechanical ventilation than currently used flow-triggering in PRVC (pressure regulated volume controlled) ventilation, and if NAVA gives real benefits for patients or not.

The investigators study hypothesis is that NAVA-technology can detect spontaneous inspiration more accurately than currently used methods, and thus will lead to more smooth adaptation to mechanical ventilation in pediatric patients. The investigators expect this to decrease the time of ventilatory support needed.


Condition Intervention
Ventilation
Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
Device: Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Primary outcome is the duration of mechanical ventilation [ Time Frame: 30minutes-3weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of sedative medication needed [ Time Frame: 30minutes-3weeks ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: September 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NAVA
Children randomised in this arm will be treated with neurally adjusted ventilatory assist
Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
Treatment with neurally adjusted ventilatory assist
Active Comparator: Control
Patients randomized to control group will be treated with pressure controlled ventilation (PC) when they are newborns and older children in this group will be treated with pressure regulated volume controlled (PRVC) ventilation.
Device: Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)
Treatment with PC or PRVC ventilation.

Detailed Description:

Asynchrony means that the timing of support given by 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 our study we randomly treat pediatric patients needing ventilatory support with neurally adjusted ventilatory assist and pressure controlled or PRVC-ventilation. We are willing to find out if there are any special benefits for patients with each treatment mode.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All children from term newborn (37+0 gestational week) to 16-year-old needing ventilatory care at least 30 minutes

Exclusion Criteria:

  • Any condition that prevents feeding tube 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: NCT01056939

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

No publications provided

Responsible Party: Merja Ålander, MD, University of Oulu
ClinicalTrials.gov Identifier: NCT01056939     History of Changes
Other Study ID Numbers: EETTMK:118/2008
Study First Received: January 19, 2010
Last Updated: May 24, 2012
Health Authority: Finland: Ministry of Social Affairs and Health
European Union: European Medicines Agency

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

ClinicalTrials.gov processed this record on July 28, 2014