Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT05173220
Status:
UNKNOWN
Last Update Posted:
2021-12-29
First Post:
2021-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of the Bougie on the Prehospital Setting Intubation Quality.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-10', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2021-12-10', 'lastUpdatePostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure of the first intubation attempt', 'timeFrame': '1 hour', 'description': 'Yes/No'}], 'secondaryOutcomes': [{'measure': 'Number of prior intubations done by operator ≤ 50', 'timeFrame': '1 hour', 'description': 'yes/No'}, {'measure': 'Operator position during intubation', 'timeFrame': '1 hour', 'description': 'Upright/on knees/Lying on the floor/Lateral left decubitus/other'}, {'measure': 'Gender', 'timeFrame': '1 hour', 'description': 'Male/female'}, {'measure': 'Age', 'timeFrame': '1 hour', 'description': 'Year'}, {'measure': 'Body mass index', 'timeFrame': '1 hour', 'description': 'kg.m 2'}, {'measure': 'Macroglossia', 'timeFrame': '1 hour', 'description': 'yes/no'}, {'measure': 'ENT tumor', 'timeFrame': '1 hour', 'description': 'Yes/no'}, {'measure': 'Inter-incisor space less than 2 fingerbreadths', 'timeFrame': '1 hour', 'description': 'yes/no'}, {'measure': 'limited head extension', 'timeFrame': '1 hour', 'description': 'Yes/no'}, {'measure': 'possible mandibular subluxation', 'timeFrame': '1 hour', 'description': 'yes/no'}, {'measure': 'thyromental length less than 3 fingerbreadths', 'timeFrame': '1 hour', 'description': 'yes/no'}, {'measure': 'Large neck size', 'timeFrame': '1 hour', 'description': 'Yes/no'}, {'measure': 'Foreign body in upper airway', 'timeFrame': '1 hour', 'description': 'Yes/no'}, {'measure': 'Upper airway bleeding/fluid', 'timeFrame': '1 hour', 'description': 'Yes/no'}, {'measure': 'Facial trauma', 'timeFrame': '1 hour', 'description': 'Yes/no'}, {'measure': 'Vomiting', 'timeFrame': '1 hour', 'description': 'Yes/no'}, {'measure': 'cardiorespiratory arrest', 'timeFrame': '1 hour', 'description': 'yes/no'}, {'measure': 'Patient on the floor', 'timeFrame': '1 hour', 'description': 'Yes/no'}, {'measure': 'Place where the intubation was done', 'timeFrame': '1 hour', 'description': 'outside/at home/others/ambulance'}, {'measure': 'restricted space', 'timeFrame': '1 hour', 'description': 'Yes/no'}, {'measure': 'if cardiac arrest, thoracic compression during intubation', 'timeFrame': '1 hour', 'description': 'Yes/no'}, {'measure': 'side events /complications during the intubation until 30 minutes after', 'timeFrame': '1 hour', 'description': 'Yes/no'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['difficult intubation', 'prehospital emergency', 'risk factors'], 'conditions': ['Tracheal Intubation Morbidity', 'Prehospital Emergency']}, 'descriptionModule': {'briefSummary': 'Tracheal intubation in an out-of-hospital setting is a frequent and potentially difficult procedure. The risk of adverse events increases dramatically with the number of attempts. The failure rate of the first intubation attempt ranges from 5 to 32% and the risk factors are unclear.\n\nIn recent study, the prevalence of a failed first intubation attempt was 31.4% \\[95% CI = 30.2-32.6\\] among 1546 patients managed in an out-of-hospital setting. In this multicenter study, our center (N=462) had a rate of 36% of failure of the first attempt. Seven variables were independently associated with a failed first intubation attempt. Some of the associated factors can be improved (operator training and experience), but most cannot. Moreover some of them can not be anticipated in this context. A randomized control trial performed in an emergency department and a prospective, observational, pre-post study design showed that systematic use of a bougie during the first intubation attempt improved the success rate.\n\nOur objective is to measure the impact of a modification of our intubation modalities introducing the incitation of the use of the bougie on the first intubation attempt in the prehospital setting.', 'detailedDescription': 'Tracheal intubation (TI) is a procedure that is frequently performed in an out-of-hospital emergency setting. TI is associated with a risk of adverse events, including severe sequelae such as hypoxemia, vomiting, aspiration, hypotension, and cardiac arrest. The risk of adverse events increases dramatically with the number of intubation attempts. Thus, it is important that the first intubation attempt succeeds. In most cases, the environment in an out-of-hospital setting is not appropriate for intubation, and can be austere (outside, restricted space, patient on the floor, or public place) or dangerous (mountain, sea, or roadside). Although literature data are abundant, they are extremely heterogenous. Indeed, the available studies differ in terms of operator profiles, TI indications, and design. Based on studies involving management by physician-led teams in out-of-hospital settings and for which data are available, the failure rate of the first intubation attempt ranges from 5% to 32%. Numerous variables are associated with difficult intubation (DI), such as more than two attempts and bad glottic visualization, but few studies have analyzed risk factors for failure of the first attempt. Identification of such factors would decrease the risk of complications.In recent study, the prevalence of a failed first intubation attempt was 31.4% \\[95% CI = 30.2-32.6\\] among 1546 patients managed in an out-of-hospital setting. In this multicenter study, our center (N=462) had a rate of 36% of failure of the first attempt. Seven variables were independently associated with a failed first intubation attempt, operator with ≤ 50 prior intubations, small inter-incisor space, limited head extension, macroglossia, ENT tumor, cardiac arrest, and vomiting.\n\nSome of the associated factors can be improved (operator training and experience), but most cannot. Moreover some of them can not be anticipated in this context. A randomized control trial performed in an emergency department showed that systematic use of a bougie during the first intubation attempt improved the success rate. A prospective, observational, pre-post study design including 823 and 771 patients respectively, showed that the use of a bougie on the first intubation attempt by paramedic in prehospital setting, improved the success rate. So we modified our intubation modalities introducing the incitation of the use of the bougie on the first intubation attempt in the prehospital setting.\n\nThe main objective of this study is to compare the rate of first intubation attempt in a new observational study performed in our center with the rate of the first assessment and to measure the impact of the introduction a systematic bougie in our intubation modalities. The secondary objective is to measure in this new cohorte rate of first intubation attempt between intubation with and without bougie.\n\nThe follow up will be restricted to the area of prehospital emergency setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with life-threatening distress requiring emergency intubation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients intubated by Emergency Medical System (EMS) team\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05173220', 'acronym': 'SMURIDS2', 'briefTitle': 'Impact of the Bougie on the Prehospital Setting Intubation Quality.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Tracheal Intubation in Emergency Prehospital Setting. Impact of the Bougie on the Failure Rate of First Intubation Attempt.', 'orgStudyIdInfo': {'id': 'CHUBX-URG-02'}}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU de BORDEAUX - Hôpital Pellegrin - Pôle Urgences adultes - SAMU', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'centralContacts': [{'name': 'MICHEL GALINSKI, M.D, Ph.D', 'role': 'CONTACT', 'email': 'michel.galinski@chu-bordeaux.fr', 'phone': '+33678549415'}], 'overallOfficials': [{'name': 'MICHEL GALINSKI, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}, {'name': 'BRUNO SIMONNET, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bruno Simonnet', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D.', 'investigatorFullName': 'Michel GALINSKI', 'investigatorAffiliation': 'University Hospital, Bordeaux'}}}}