This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.
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
Enrollment
60
Hospital Universitario La Paz
Madrid, Madrid, Spain
RECRUITINGAvoiding endotracheal intubation using non-invasive ventilation
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.
Time frame: During non invasive ventilation, an average of 2-3 days.
Length (days) of endotracheal intubation (conventional mechanical ventilation) after NIV
Time frame: During mechanical ventilation after NIV
Length (days) of PICU stay after NIV
The patients will be follow up after NIV during the PICU stay, and average of two weeks
Time frame: After NIV
Length (days) hospital stay after NIV
The patients will be follow up after NIV during hospital stay, an average of 2-3 weeks.
Time frame: After NIV
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