Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients

Not Applicable

Completed

• Conditions: Ventilation
• Interventions: Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden); Device: Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)

• Registration Number: NCT01056939
• Lead Sponsor: University of Oulu

Brief 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.

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-24
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAVA	Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)	Children randomised in this arm will be treated with neurally adjusted ventilatory assist
Control	Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)	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.

Primary Outcome Measures

Name	Time	Method
Primary outcome is the duration of mechanical ventilation	30minutes-3weeks

Secondary Outcome Measures

Name	Time	Method
Amount of sedative medication needed	30minutes-3weeks

Trial Locations

Locations (1)

University Hospital of Oulu; 🇫🇮 Oulu, Finland