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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Avoiding 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. | During non invasive ventilation, an average of 2-3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Length (days) of endotracheal intubation (conventional mechanical ventilation) after NIV | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Children from 1 month to 18 years admitted to the PICU with moderate/severe acute respiratory failure minimally sedated/agitated
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro De la Oliva, MD, PhD | Contact | +347277149 | poliva.hulp@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert M Kacmarek, PhD RRT FCCM | Massachusetts General Hospital, Boston, USA | Study Director |
| Jesús Villar, MD, PhD | Hospital Universitario Dr. Negrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Recruiting | Madrid | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12667269 | Background | Cheifetz IM. Invasive and noninvasive pediatric mechanical ventilation. Respir Care. 2003 Apr;48(4):442-53; discussion 453-8. | |
| 17290566 | Background | Kendirli T, Kavaz A, Yalaki Z, Ozturk Hismi B, Derelli E, Ince E. Mechanical ventilation in children. Turk J Pediatr. 2006 Oct-Dec;48(4):323-7. |
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| 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. | After NIV |
| 14968216 | Background | Al-Mutairi SS, Al-Deen JS. Non-invasive positive pressure ventilation in acute respiratory failure. An alternative modality to invasive ventilation at a general hospital. Saudi Med J. 2004 Feb;25(2):190-4. |
| 9827833 | Background | L'HerE, Moriconi M, Texier F, Bouquin V, Kaba L, Renault A, Garo B, Boles JM. Non-invasive continuous positive airway pressure in acute hypoxaemic respiratory failure--experience of an emergency department. Eur J Emerg Med. 1998 Sep;5(3):313-8. |
| 16276332 | Background | Bernet V, Hug MI, Frey B. Predictive factors for the success of noninvasive mask ventilation in infants and children with acute respiratory failure. Pediatr Crit Care Med. 2005 Nov;6(6):660-4. doi: 10.1097/01.pcc.0000170612.16938.f6. |
| 20440111 | Background | Calderini E, Chidini G, Pelosi P. What are the current indications for noninvasive ventilation in children? Curr Opin Anaesthesiol. 2010 Jun;23(3):368-74. doi: 10.1097/ACO.0b013e328339507b. |
| 15599160 | Background | Keenan SP, Sinuff T, Cook DJ, Hill NS. Does noninvasive positive pressure ventilation improve outcome in acute hypoxemic respiratory failure? A systematic review. Crit Care Med. 2004 Dec;32(12):2516-23. doi: 10.1097/01.ccm.0000148011.51681.e2. |
| 18712350 | Background | Essouri S, Durand P, Chevret L, Haas V, Perot C, Clement A, Devictor D, Fauroux B. Physiological effects of noninvasive positive ventilation during acute moderate hypercapnic respiratory insufficiency in children. Intensive Care Med. 2008 Dec;34(12):2248-55. doi: 10.1007/s00134-008-1202-9. Epub 2008 Aug 19. |
| 19593246 | Background | Breatnach C, Conlon NP, Stack M, Healy M, O'Hare BP. A prospective crossover comparison of neurally adjusted ventilatory assist and pressure-support ventilation in a pediatric and neonatal intensive care unit population. Pediatr Crit Care Med. 2010 Jan;11(1):7-11. doi: 10.1097/PCC.0b013e3181b0630f. |
| 20828233 | Background | Biban P, Serra A, Polese G, Soffiati M, Santuz P. Neurally adjusted ventilatory assist: a new approach to mechanically ventilated infants. J Matern Fetal Neonatal Med. 2010 Oct;23 Suppl 3:38-40. doi: 10.3109/14767058.2010.510018. |
| 20308933 | Background | Munoz-Bonet JI, Flor-Macian EM, Brines J, Rosello-Millet PM, Cruz Llopis M, Lopez-Prats JL, Castillo S. Predictive factors for the outcome of noninvasive ventilation in pediatric acute respiratory failure. Pediatr Crit Care Med. 2010 Nov;11(6):675-80. doi: 10.1097/PCC.0b013e3181d8e303. |