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- Essai clinique NCT01873261
NIV NAVA Versus NIV-PS in Pediatric Patients - Pilot Study (NINAVAPed)
Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support in Pediatric Acute Respiratory Failure - Pilot Study
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Pedro De la Oliva, MD, PhD
- Numéro de téléphone: +347277149
- E-mail: poliva.hulp@salud.madrid.org
Lieux d'étude
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Madrid, Espagne, 28046
- Recrutement
- Hospital Universitario La Paz
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Contact:
- Pedro De la Oliva, MD,PhD
- Numéro de téléphone: 0034917277149
- E-mail: poliva.hulp@salud.madrid.org
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Chercheur principal:
- Pedro De la Oliva, MD, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Age: > 1 month age to 18 years
- Moderate/severe Pediatric Acute Respiratory failure of any origin evaluated after a period of respiratory stabilization (aspiration of secretions, physiotherapy, oxygen and nebulized therapy) when the attending pediatric intensive care physician believes that the patient is likely to require endotracheal intubation (ETI).
- Non intubated
- Admitted to the PICU
- Minimally agitated/sedated: between -2 and +2 on the Richmond agitation-sedation scale (Table 2)
Exclusion Criteria:
- Patients younger than 1 month or older than 18 year
- Patients who need immediate endotracheal intubation: i.e.: Severe ARF with signs of exhaustion
- Facial trauma/burns
- Recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding
- Fixed obstruction of the upper airway
- Inability to protect airway
- Life threatening hypoxemia defined as SpaO2 <90% with FiO2 > 0.8 on hi-flow oxygen.
- Hemodynamic instability: refractory at volume expansion >60 ml/kg and dopamine >10 mcg/kg/min
- Impaired consciousness defined as Glasgow coma scale < 10.
- Bowel obstruction.
- Untreated pneumothorax.
- Poor short term prognosis (high risk of death in the next 3 months)
- Known esophageal problem (hiatal hernia, esophageal varicosities)
- Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a NG tube.
- Neuromuscular disease
- Vomiting
- Cough or gag reflex impairment.
- Cyanotic congenital heart disease.
- Complete absence of cooperation
- This patient has been included (randomized) previously in the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Avoiding endotracheal intubation using non-invasive ventilation
Délai: During non invasive ventilation, an average of 2-3 days.
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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.
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During non invasive ventilation, an average of 2-3 days.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Length (days) of endotracheal intubation (conventional mechanical ventilation) after NIV
Délai: During mechanical ventilation after NIV
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During mechanical ventilation after NIV
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Length (days) of PICU stay after NIV
Délai: After NIV
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The patients will be follow up after NIV during the PICU stay, and average of two weeks
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After NIV
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Length (days) hospital stay after NIV
Délai: After NIV
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The patients will be follow up after NIV during hospital stay, an average of 2-3 weeks.
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After NIV
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jesús Villar, MD, PhD, Hospital Universitario Dr. Negrin
- Directeur d'études: Robert M Kacmarek, PhD RRT FCCM, Massachusetts General Hospital, Boston, USA
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
- Cheifetz IM. Invasive and noninvasive pediatric mechanical ventilation. Respir Care. 2003 Apr;48(4):442-53; discussion 453-8.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HULP-PI-3750
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