Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients

University of Oulu

Status: Completed

Conditions: Ventilation

Treatments: 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

Funder types: Other

Identifiers

NCT01056939

EETTMK:118/2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 1 minute to 16 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

NAVA

Active Comparator group

Description:

Children randomised in this arm will be treated with neurally adjusted ventilatory assist

Treatment:

Device: Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)

Control

Active Comparator group

Description:

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.

Treatment:

Device: Control (PC- or PRVC- ventilation), i-Servo, Maquet Nordic (Solna, Sweden)