Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients
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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 |
- Primary outcome is the duration of mechanical ventilation [ Time Frame: 30minutes-3weeks ] [ Designated as safety issue: No ]
- 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 |
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 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 May 16, 2013