Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT00678912
Status:
COMPLETED
Last Update Posted:
2025-12-18
First Post:
2008-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Weaning Children From Mechanical Ventilation:Computer-driven System Versus Usual Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2008-05-14', 'studyFirstSubmitQcDate': '2008-05-15', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation.', 'timeFrame': 'first extubation or 28 days'}], 'secondaryOutcomes': [{'measure': 'Total mechanical ventilation duration', 'timeFrame': 'first extubation or 28 days'}, {'measure': 'Proportion of time in the acceptable breathing zone', 'timeFrame': 'first extubation or 28 days'}, {'measure': 'Weaning failure', 'timeFrame': '48 hours after first extubation'}, {'measure': 'Number of interventions on the ventilator by a physician or physiotherapist', 'timeFrame': 'First extubation or 28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mechanical ventilation', 'automated weaning', 'children'], 'conditions': ['Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '17693913', 'type': 'BACKGROUND', 'citation': 'Jouvet P, Farges C, Hatzakis G, Monir A, Lesage F, Dupic L, Brochard L, Hubert P. Weaning children from mechanical ventilation with a computer-driven system (closed-loop protocol): a pilot study. Pediatr Crit Care Med. 2007 Sep;8(5):425-32. doi: 10.1097/01.PCC.0000282157.77811.F9.'}, {'pmid': '23361631', 'type': 'DERIVED', 'citation': 'Jouvet PA, Payen V, Gauvin F, Emeriaud G, Lacroix J. Weaning children from mechanical ventilation with a computer-driven protocol: a pilot trial. Intensive Care Med. 2013 May;39(5):919-25. doi: 10.1007/s00134-013-2837-8. Epub 2013 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a computer-driven system (Smartcare/PS) decreases weaning duration from mechanical ventilation when compared to usual care in children.', 'detailedDescription': "Baseline data: All subjects included into this RCT will undergo routine examination upon admission to the hospital. These examinations include physical, medical/medication history (on the last year for medical history and the last 3 months for medication history (if available), vital signs, radiologic data and laboratory tests.\n\nIntervention: A pre-inclusion test (pressure support test) with a level of pressure support of ± 5 cmH2O of the P plateau, but no greater than 30 cmH2O (pressure-support level plus positive end-expiratory pressure), is performed to evaluate the patient's tolerance of this ventilation mode; the test is repeated daily until positive. The test could be stopped before 30 minutes if the patient showed evidence of respiratory distress (respiratory rate \\> 40 breaths per minute and FiO2 \\> 60% in order to obtain pulse oxymetry ≥ 95%). The test is considered positive when, after 30 minutes, the patient remained clinically stable with a respiratory rate lower than 40 breaths per minute and an expiratory tidal volume higher than 6 ml per kilogram of body weight within the authorized pressure-support range, with pulse oxymetry no lower than 95 percent when the fraction of inspired oxygen was no greater than 60 percent. When the pressure-support test is positive, the patient is randomized either to Arm 1 where the intervention is weaning with the support of Smartcare/PS or to Arm 2 where the intervention is weaning based on usual care. Both group are ventilated with the same ventilator: Evita XL."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The attending physician thinks that the patient will be able to breathe spontaneously or the patients is already breathing spontaneously.\n* No vasopressor or inotropic medication, unless the patient is receiving some digitalin or small doses of dopamine (\\< 5 µg/kg/min)\n* Slight or no endotracheal tube gas-leakage (\\[Vti - Vte\\]/Vti ≤ 20%)\n* Mechanical ventilation with a plateau pressure ≤ 25 cmH2O over PEEP\n* PEEP ≤ 8 cmH2O\n* FiO2 ≤ 60% in order to obtain pulse oxymetry ≥ 95%\n* PaCO2 \\< 70 mmHg on the last blood gases\n* Extubation not expected the day of inclusion\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT00678912', 'briefTitle': 'Weaning Children From Mechanical Ventilation:Computer-driven System Versus Usual Care', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'officialTitle': 'Single Center Randomized Clinical Trial Comparing Weaning From Mechanical Ventilation With Computer-driven System vs Usual Care in Children', 'orgStudyIdInfo': {'id': 'CHUSJ-2239'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Children are mechanically ventilated with Smartcare/PS', 'interventionNames': ['Device: Smartcare/PS']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Children are mechanically ventilated with usual care'}], 'interventions': [{'name': 'Smartcare/PS', 'type': 'DEVICE', 'otherNames': ['Weaning from mechanical ventilation with Smartcare/PS'], 'description': 'computer-driven protocol that adjusts pressure support level in pressure support mode to patient respiratory status', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU Sainte Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Philippe A Jouvet, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montreal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Justine's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Philippe Jouvet', 'investigatorAffiliation': "St. Justine's Hospital"}}}}