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NCT01056939 Clinical Trial

Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients

Ventilation Clinical Trial

Official title:
Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01056939
Other study ID # EETTMK:118/2008
Secondary ID
Status Completed
Phase N/A
First received January 19, 2010
Last updated May 24, 2012
Start date September 2009
Est. completion date May 2012

Study information
Verified date May 2012
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority Finland: Ministry of Social Affairs and HealthEuropean Union: European Medicines Agency
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 170
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 16 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)
Treatment with neurally adjusted ventilatory assist
• Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)
Treatment with PC or PRVC ventilation.

Locations
Country Name City State
Finland University Hospital of Oulu Oulu

Sponsors (1)
Lead Sponsor Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary outcome is the duration of mechanical ventilation 30minutes-3weeks No
Secondary Amount of sedative medication needed 30minutes-3weeks No
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