NIV NAVA Versus NIV-PS in Pediatric Patients - Pilot Study (NINAVAPed)
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|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.
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): NCT01873261
|Contact: Pedro De la Oliva, MD, PhDemail@example.com|
|Hospital Universitario La Paz||Recruiting|
|Madrid, Spain, 28046|
|Contact: Pedro De la Oliva, MD,PhD 0034917277149 firstname.lastname@example.org|
|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|