Neurally Adjusted Ventilatory Assist (NAVA) vs. Pressure Support in Pediatric Acute Respiratory Failure (NiNAVAped)
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|ClinicalTrials.gov Identifier: NCT01873521|
Recruitment Status : Unknown
Verified April 2014 by Ignacio Galicia, Hospital Universitario La Paz.
Recruitment status was: Recruiting
First Posted : June 10, 2013
Last Update Posted : April 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Acute Respiratory Failure||Procedure: Non invasive ventilation||Phase 4|
Mechanical ventilation (MV) refers to the use of life-support technology to perform the work of breathing for patients who are unable to breathe on their own. One of the most common reasons for a Pediatric Intensive Care Unit (PICU) admission is the need for mechanical ventilation. However, MV is associated with increased morbidity (endotracheal intubation, tracheal edema, atelectasis, cardiovascular instability, ventilator-associated pneumonia, bleeding, pneumothorax, chronic lung disease, etc), a long length of stay in the PICU and high health care costs. Noninvasive ventilation (NIV) has become a primary approach to ventilatory support of patients of all ages and it is estimated that it can avoid endotracheal intubation and replace conventional mechanical ventilation in around 60% of patients with acute respiratory failure. NIV has been shown to ameliorate clinical signs of failure and improve gas exchange while reducing the need for endotracheal intubation (ETI) thus avoiding the risks associated with invasive ventilation. NIV has been shown to decrease the length of mechanical ventilation, the risk of ventilator associated pneumonia, the sedation requirement, the length of ICU and hospital stay and mortality, while improving the ability to tolerate enteral feeds. NIV does not increase beside caregiver time and does decrease cost.
With children because of the difficulty in assuring the patient's cooperation, the lack of available high quality masks and the resulting size of the air leak, synchrony between the ventilatory pattern of the patient and the support provided by the ventilator is poor. This problem had lead to repeated failure of noninvasive ventilation in children. The primary mode of noninvasive ventilatory support is pressure support (NIV PS). This mode is triggered to inspiration and cycled to exhalation by changes in patient inspiratory gas flow. But with air leaks the ability of the ventilator to coordinate with the patient is decreased.
A new mode of ventilation, Neurally Adjusted Ventilatory Assist (NAVA) has been recently introduced. This mode triggers, cycles and regulates gas delivery based on the diaphragmatic EMG signal via a specially designed nasogastric tube (Edi). As a result, air leaks do not affect the ability of the ventilator to synchronize gas delivery with the patient increasing patient ventilator synchrony. Based on the operation of NAVA it is expected to increase the successful application of noninvasive ventilation to children.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Multicentre, Randomized, Clinical Trial of Noninvasive Ventilation: Neurally Adjusted Ventilatory Assist (NAVA) vs. Pressure Support in Pediatric Acute Respiratory Failure - NINAVAPed Protocol|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||December 2016|
Active Comparator: NIV PS
The patients in this arms will received non invasive ventilation in PS mode.
Procedure: Non invasive ventilation
Active Comparator: NIV NAVA
The patients in this arm will received non invasive ventilation in NAVA mode.
Procedure: Non invasive ventilation
- Avoiding endotracheal intubation [ Time Frame: During non invasive ventilation, an average of 2-3 days. ]The primary objective of this study is to demonstrate that the use of NAVA to provide noninvasive ventilatory support (NIV NAVA) compared to pressure support (NIV PS) in pediatric patients with moderate to severe respiratory failure decreases the noninvasive ventilation failure rate by decreasing the number of patients requiring endotracheal intubation (ETI).
- Length (days) of PICU stay after NIV [ Time Frame: Length (days) of PICU stay after NIV, an average of 1 week. ]
- Length (days) hospital stay after NIV [ Time Frame: Length (days) hospital stay after NIV, an average of 1-2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873521
|Contact: Pedro De la Oliva, MD, PhDfirstname.lastname@example.org|
|Hospital Universitario La Paz||Recruiting|
|Madrid, Spain, 28046|
|Contact: Pedro De la Oliva, MD,PhD +34917277149 email@example.com|
|Principal Investigator: Pedro De la Oliva, MD,PhD|
|Sub-Investigator: Ana Gómez-Zamora, MD|
|Sub-Investigator: Cristina Schüffelmann, MD|
|Study Director:||Robert M Kacmarek, PhD RRT FCCM||Massachusetts General Hospital, Boston, USA|
|Principal Investigator:||Jesús Villar, MD,PhD||Hospital Universitario Dr. Negrin|