Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-07 @ 6:44 PM
Study NCT ID:
NCT00472160
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
2007-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoxygenation Using NIV in Hypoxemic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-25', 'studyFirstSubmitDate': '2007-05-10', 'studyFirstSubmitQcDate': '2007-05-10', 'lastUpdatePostDateStruct': {'date': '2011-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation.', 'timeFrame': 'the first week'}], 'secondaryOutcomes': [{'measure': 'The mean drop in SpO2 during endotracheal intubation.', 'timeFrame': 'during the intubation'}, {'measure': 'Number of organ failures (SOFA score >2)', 'timeFrame': 'during the 7 days after intubation'}, {'measure': 'ICU length of stay', 'timeFrame': 'during the stay in reanimation'}, {'measure': 'Mortality', 'timeFrame': 'in reanimation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preoxygenation', 'Non Invasive Ventilation', 'Continuous Positive Airway Pressure,', 'Intubation,', 'Organ failure'], 'conditions': ['Critical Illness', 'Hypoxemia']}, 'referencesModule': {'references': [{'pmid': '16627862', 'type': 'RESULT', 'citation': 'Baillard C, Fosse JP, Sebbane M, Chanques G, Vincent F, Courouble P, Cohen Y, Eledjam JJ, Adnet F, Jaber S. Noninvasive ventilation improves preoxygenation before intubation of hypoxic patients. Am J Respir Crit Care Med. 2006 Jul 15;174(2):171-7. doi: 10.1164/rccm.200509-1507OC. Epub 2006 Apr 20.'}, {'pmid': '29406184', 'type': 'DERIVED', 'citation': 'Baillard C, Prat G, Jung B, Futier E, Lefrant JY, Vincent F, Hamdi A, Vicaut E, Jaber S. Effect of preoxygenation using non-invasive ventilation before intubation on subsequent organ failures in hypoxaemic patients: a randomised clinical trial. Br J Anaesth. 2018 Feb;120(2):361-367. doi: 10.1016/j.bja.2017.11.067. Epub 2017 Nov 23.'}]}, 'descriptionModule': {'briefSummary': 'Critically ill patients are predisposed to oxyhaemoglobin desaturation during intubation. For the intubation of hypoxemic patients, preoxygenation using non invasive ventilation (NIV) is more effective at reducing arterial oxyhaemoglobin desaturation than standard method.\n\nObjectives: To find out whether NIV, as a preoxygenation method, is more effective at reducing the degree of organ dysfunction/failure than standard preoxygenation during the week following endotracheal intubation.', 'detailedDescription': 'During the inclusion period (at least 10 min and maximum 30 min), the patients ware a high FiO2 mask, driven by 10-15L/min oxygen and are randomly assigned to control or NIV group. Preoxygenation is then performed for a 3 minute period prior to a standardized rapid sequence intubation. For the control group, preoxygenation use a non-re-breather bag-valve mask driven by 15L/min oxygen. Patients allow to breath spontaneously with occasional assists (usual preoxygenation method). For the NIV group, pressure support mode is delivered by an ICU ventilator through a face mask adjusted to obtain an expired tidal volume of 7 to 10 mL/kg. The fraction of inspired oxygen (FiO2) was 100% and we used a PEEP level of 5 cmH2O.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults patients with acute respiratory failure requiring intubation\n\nExclusion Criteria:\n\n* Encephalopathy or coma, cardiac resuscitation'}, 'identificationModule': {'nctId': 'NCT00472160', 'acronym': 'PREOXY', 'briefTitle': 'Preoxygenation Using NIV in Hypoxemic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients', 'orgStudyIdInfo': {'id': 'P060230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Non Invasive Ventilation', 'interventionNames': ['Procedure: Non Invasive Ventilation']}], 'interventions': [{'name': 'Non Invasive Ventilation', 'type': 'PROCEDURE', 'description': 'Non Invasive Ventilation', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'Hopital de Bobigny', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}], 'overallOfficials': [{'name': 'Christophe BAILLARD, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cecile JOURDAIN', 'oldOrganization': 'Department Clinical Research of Developpement'}}}}