Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01056939

Enrollment

170

Registered

2010-01-26

Start date

2009-09-30

Completion date

2012-05-31

Last updated

2012-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilation

Keywords

Ventilatory care, children, intensive care, NAVA, Children needing ventilatory care

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.

Interventions

DEVICENeurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)

Treatment with neurally adjusted ventilatory assist

DEVICEControl (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)

Treatment with PC or PRVC ventilation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Minutes to 16 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Primary outcome is the duration of mechanical ventilation	30minutes-3weeks

Secondary

Measure	Time frame
Amount of sedative medication needed	30minutes-3weeks

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026