Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2025-12-29 @ 11:30 PM
Study NCT ID:
NCT01374061
Status:
WITHDRAWN
Last Update Posted:
2014-05-08
First Post:
2011-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre Hospital Evaluation of Video Laryngoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-07', 'studyFirstSubmitDate': '2011-05-25', 'studyFirstSubmitQcDate': '2011-06-14', 'lastUpdatePostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IDS score in each group', 'timeFrame': 'during the intubation'}], 'secondaryOutcomes': [{'measure': 'Vomit / regurgitation or inhalation per-procedure', 'timeFrame': 'during the intubation'}, {'measure': 'Dental or throat traumatism', 'timeFrame': 'during the intubation'}, {'measure': 'Broncho/laryngospasm', 'timeFrame': 'during the intubation'}, {'measure': 'Hypoxia', 'timeFrame': 'per intubation'}, {'measure': 'Hemodynamic instability', 'timeFrame': 'per intubation'}, {'measure': 'Inhalation pneumonia', 'timeFrame': 'within 24 hours following the inclusion'}, {'measure': 'Failure of intubate', 'timeFrame': 'during the intubation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Emergency intubation', 'Glide scope Ranger', 'Pre hospital'], 'conditions': ['Cardiac Arrest', 'Respiratory Distress Syndrome', 'Shock', 'Acute Post-trauma Stress State', 'Drug Toxicity', 'Trauma, Nervous System']}, 'descriptionModule': {'briefSummary': 'The objective of this work is to compare standard intubation with video laryngoscope (Glide scope Ranger ) in French pre hospital multicentric study.', 'detailedDescription': 'Introduction: In France, patients in critical status brought to hospital by emergency physicians and nurses experimented in tracheal intubation. It is an invasive act allowing a protection of airways and an optimal oxygenation of the patients in distress. The reference technique is the direct laryngoscopy by Macintosh . Corresponding data shows that a video laryngoscope - GLIDESCOPE laryngoscope - improve the conditions of intubation in the surgical unit thanks to a better display(visualization) of the opening. A derived device for pre hospital emergency units (GLIDESCOPE Ranger®) deserves to be compared with the classic laryngoscopy in emergency conditions.\n\nObjectives: compare the emergency intubation in Pre hospital meadow by Glide Scope Ranger with regard to the classic method\n\nProgress of the study: the patients will be included by emergency physicians working in out of hospital teams of 3 major hospitals of Paris. The patients will be randomized in 2 groups: 1 group classic laryngoscopy (group 1) and a group Glide scope Ranger (group 2). The score IDS will be compared for every group as well as the arisen of a complication during the procedure. The consent will be collected on the place or during the hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients of more than 18 years old\n* requiring an intubation\n* by medical out of hospital emergency operators\n* medical insurance\n* Consent signed\n\nExclusion Criteria:\n\n* Age \\<18, pregnant women\n* Refusal of consent or inability for understanding study\n* small mouth opening makes it impossible intubate'}, 'identificationModule': {'nctId': 'NCT01374061', 'acronym': 'EVE', 'briefTitle': 'Pre Hospital Evaluation of Video Laryngoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Pre Hospital Evaluation of Video Laryngoscopy : a Comparative Study of Macintosh and GLIDESCOPE Ranger®', 'orgStudyIdInfo': {'id': 'P100205'}, 'secondaryIdInfos': [{'id': '2010-A01512-37', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1: Classical intubation', 'interventionNames': ['Device: Classical intubation']}, {'type': 'EXPERIMENTAL', 'label': '2: Glidescope intubation', 'interventionNames': ['Device: GLIDESCOPE']}], 'interventions': [{'name': 'Classical intubation', 'type': 'DEVICE', 'description': 'Classical intubation', 'armGroupLabels': ['1: Classical intubation']}, {'name': 'GLIDESCOPE', 'type': 'DEVICE', 'description': 'GLIDESCOPE intubation', 'armGroupLabels': ['2: Glidescope intubation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sébastien GALLULA, Ph', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Patrick PLAISANCE, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}