Neurally Adjusted Ventilatory Assist (NAVA) in Pediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Pressure-, Flow- and Neurally Adjusted Ventilatory Assistance (NAVA)-Triggering in Pediatric and Neonatal Ventilatory Care

NCT00893087

Respiration

COMPLETED NA

Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)

NCT01426178

Respiratory Insufficiency

COMPLETED PHASE1

Adjusted Ventilatory Assist (NAVA-NIV) in Infants: Short-term Physiological Study

NCT02043990

Acute Respiratory Failure

UNKNOWN NA

Regional Distribution Differences Between Neurally Adjusted Ventilatory Assist and Pressure Support Ventilation

NCT01504373

Respiratory Failure

COMPLETED

NAVA Helmet in Pediatric Respiratory Failure

NCT02050217

Acute Respiratory Failure With Hypoxia

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventilation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NAVA

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Treatment with neurally adjusted ventilatory assist

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.

Group Type ACTIVE_COMPARATOR