Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients
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|ClinicalTrials.gov Identifier: NCT01056939|
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : May 25, 2012
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 or disease||Intervention/treatment||Phase|
|Ventilation||Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden) Device: Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
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.
- Primary outcome is the duration of mechanical ventilation [ Time Frame: 30minutes-3weeks ]
- Amount of sedative medication needed [ Time Frame: 30minutes-3weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056939
|University Hospital of Oulu|