Ignite Creation Date:
2025-12-17 @ 1:44 PM
Ignite Modification Date:
2025-12-23 @ 4:54 PM
Study NCT ID:
NCT01873261
Status:
UNKNOWN
Last Update Posted:
2013-06-10
First Post:
2013-02-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NIV NAVA Versus NIV-PS in Pediatric Patients - Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-07', 'studyFirstSubmitDate': '2013-02-19', 'studyFirstSubmitQcDate': '2013-06-07', 'lastUpdatePostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Avoiding endotracheal intubation using non-invasive ventilation', 'timeFrame': 'During non invasive ventilation, an average of 2-3 days.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Length (days) of endotracheal intubation (conventional mechanical ventilation) after NIV', 'timeFrame': 'During mechanical ventilation after NIV'}, {'measure': 'Length (days) of PICU stay after NIV', 'timeFrame': 'After NIV', 'description': 'The patients will be follow up after NIV during the PICU stay, and average of two weeks'}, {'measure': 'Length (days) hospital stay after NIV', 'timeFrame': 'After NIV', 'description': 'The patients will be follow up after NIV during hospital stay, an average of 2-3 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neurally Adjusted Ventilatory Assist', 'Pediatric Acute Respiratory Failure', 'non-invasive ventilation'], 'conditions': ['Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '12667269', 'type': 'BACKGROUND', 'citation': 'Cheifetz IM. Invasive and noninvasive pediatric mechanical ventilation. Respir Care. 2003 Apr;48(4):442-53; discussion 453-8.'}, {'pmid': '17290566', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '14968216', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9827833', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '16276332', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20440111', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15599160', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18712350', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19593246', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '20828233', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20308933', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.', 'detailedDescription': 'This pilot study will be an observational no randomize study in which the NiNAVAped protocol will be applied solely to the NIV NAVA arm.\n\nEvery 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.\n\nShould the Pilot study reveal deficiencies in the NiNAVAped design, the protocol would be improved accordingly.\n\nThere will be a specific consent document during the Pilot study. The Pilot study will be published in a scientific journal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children from 1 month to 18 years admitted to the PICU with moderate/severe acute respiratory failure minimally sedated/agitated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: \\> 1 month age to 18 years\n* 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).\n* Non intubated\n* Admitted to the PICU\n* Minimally agitated/sedated: between -2 and +2 on the Richmond agitation-sedation scale (Table 2)\n\nExclusion Criteria:\n\n1. Patients younger than 1 month or older than 18 year\n2. Patients who need immediate endotracheal intubation: i.e.: Severe ARF with signs of exhaustion\n3. Facial trauma/burns\n4. Recent facial, upper way, or upper gastrointestinal tract surgery excepting gastrostomy for feeding\n5. Fixed obstruction of the upper airway\n6. Inability to protect airway\n7. Life threatening hypoxemia defined as SpaO2 \\<90% with FiO2 \\> 0.8 on hi-flow oxygen.\n8. Hemodynamic instability: refractory at volume expansion \\>60 ml/kg and dopamine \\>10 mcg/kg/min\n9. Impaired consciousness defined as Glasgow coma scale \\< 10.\n10. Bowel obstruction.\n11. Untreated pneumothorax.\n12. Poor short term prognosis (high risk of death in the next 3 months)\n13. Known esophageal problem (hiatal hernia, esophageal varicosities)\n14. Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a NG tube.\n15. Neuromuscular disease\n16. Vomiting\n17. Cough or gag reflex impairment.\n18. Cyanotic congenital heart disease.\n19. Complete absence of cooperation\n20. This patient has been included (randomized) previously in the study'}, 'identificationModule': {'nctId': 'NCT01873261', 'acronym': 'NINAVAPed', 'briefTitle': 'NIV NAVA Versus NIV-PS in Pediatric Patients - Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Paz'}, 'officialTitle': 'Neurally Adjusted Ventilatory Assist (NAVA) Versus Pressure Support in Pediatric Acute Respiratory Failure - Pilot Study', 'orgStudyIdInfo': {'id': 'HULP-PI-3750'}}, 'contactsLocationsModule': {'locations': [{'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pedro De la Oliva, MD,PhD', 'role': 'CONTACT', 'email': 'poliva.hulp@salud.madrid.org', 'phone': '0034917277149'}, {'name': 'Pedro De la Oliva, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Pedro De la Oliva, MD, PhD', 'role': 'CONTACT', 'email': 'poliva.hulp@salud.madrid.org', 'phone': '+347277149'}], 'overallOfficials': [{'name': 'Robert M Kacmarek, PhD RRT FCCM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Massachusetts General Hospital, Boston, USA'}, {'name': 'Jesús Villar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Dr. Negrin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ignacio Galicia', 'investigatorAffiliation': 'Hospital Universitario La Paz'}}}}