NIV NAVA Versus NIV-PS in Pediatric Patients - Pilot Study (NINAVAPed)
|ClinicalTrials.gov Identifier: NCT01873261|
Recruitment Status : Unknown
Verified June 2013 by Ignacio Galicia, Hospital Universitario La Paz.
Recruitment status was: Recruiting
First Posted : June 10, 2013
Last Update Posted : June 10, 2013
|Condition or disease|
|Acute Respiratory Failure|
This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.
Every PICU will have to include 3 patients in the Pilot study before starting the clinical trial, which means that the pilot study will involve a maximum of 60 patients.
Should the Pilot study reveal deficiencies in the NiNAVAped design, the protocol would be improved accordingly.
There will be a specific consent document during the Pilot study. The Pilot study will be published in a scientific journal.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support in Pediatric Acute Respiratory Failure - Pilot Study|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
- Avoiding endotracheal intubation using non-invasive ventilation [ Time Frame: During non invasive ventilation, an average of 2-3 days. ]The primary endpoint of this study is avoiding endotracheal intubation (ETI) (and conventional mechanical ventilation (MV)) using non-invasive ventilation (NIV). It is defined as no need for ETI (and MV) for at least 48h after the withdrawal of NIV.
- Length (days) of endotracheal intubation (conventional mechanical ventilation) after NIV [ Time Frame: During mechanical ventilation after NIV ]
- Length (days) of PICU stay after NIV [ Time Frame: After NIV ]The patients will be follow up after NIV during the PICU stay, and average of two weeks
- Length (days) hospital stay after NIV [ Time Frame: After NIV ]The patients will be follow up after NIV during hospital stay, an average of 2-3 weeks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873261
|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 0034917277149 email@example.com|
|Principal Investigator: Pedro De la Oliva, MD, PhD|
|Study Director:||Robert M Kacmarek, PhD RRT FCCM||Massachusetts General Hospital, Boston, USA|
|Principal Investigator:||Jesús Villar, MD, PhD||Hospital Universitario Dr. Negrin|