Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-28 @ 6:26 PM
Study NCT ID:
NCT06307392
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 710}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-03-06', 'studyFirstSubmitQcDate': '2024-03-06', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of first pass success during prehospital emergency intubation', 'timeFrame': 'Within 10 minutes following blade introduction', 'description': 'Successful intubation on first attempt'}], 'secondaryOutcomes': [{'measure': 'Occurrence of hypoxia', 'timeFrame': 'Within 1 hour following intubation', 'description': 'SpO2 (pulsed oxygen saturation) \\<90%'}, {'measure': 'Occurrence of bradycardia', 'timeFrame': 'Within 1 hour following intubation', 'description': 'Heart rate \\<50 bpm'}, {'measure': 'Occurrence of cardiac arrest', 'timeFrame': 'Within 1 hour following intubation'}, {'measure': 'Occurrence of death', 'timeFrame': 'Within 1 hour following intubation'}, {'measure': 'Occurrence of pulmonary aspirations', 'timeFrame': 'Within 1 hour following intubation'}, {'measure': 'Occurrence of severe cardiovascular collapse', 'timeFrame': 'Within 1 hour following intubation', 'description': 'Systolic blood pressure less than 65mmHg recorded at least once or less than 90 mmHg lasting 30 minutes despite 500-1,000 ml of fluid loading (crystalloids) or requiring introduction or increasing doses by more than 30% of vasoactive support'}, {'measure': 'Time between blade introduction to the confirmation of a correct tube placement', 'timeFrame': 'Within 15 minutes following blade introduction', 'description': 'In minutes. The correct position of the endotracheal tube is confirmed by detection of end-tidal carbon dioxide.'}, {'measure': 'Change in SpO2 (pulsed oxygen saturation) from the time of induction to lowest SpO2 up to 2 minutes after confirmation of correct tube placement', 'timeFrame': 'Within 15 minutes following induction', 'description': 'In percentage'}, {'measure': 'Occurrence of change in SpO2 of more than 3% from the time of induction to 2 minutes after confirmation of correct tube placement', 'timeFrame': 'Within 15 minutes following induction'}, {'measure': 'Cormack-Lehane grade of glottic view at first intubation attempt', 'timeFrame': 'Within 10 minutes following first blade introduction'}, {'measure': 'Number of laryngoscopies attempts to achieve correct endotracheal tube placement', 'timeFrame': 'Within 30 minutes following first blade introduction'}, {'measure': 'Number of patients for whom the placement of an endotracheal tube was not possible in the pre-hospital setting', 'timeFrame': 'Within 30 minutes following first blade introduction'}, {'measure': 'Difficulty perceived by the operator on first intubation attempt', 'timeFrame': 'Within 10 minutes following blade introduction', 'description': '3-point Likert scale'}, {'measure': 'Occurrence of injuries', 'timeFrame': 'Within 24 hours following intubation', 'description': 'Occurrence (yes/no) of injuries related to the intubation:\n\nmucosal bleeding, laryngeal, tracheal, bronchial, mediastinal or oesophageal injuries'}, {'measure': 'Occurrence of complications', 'timeFrame': 'Within 48 hours following intubation', 'description': 'Occurrence (yes/no) of complications related to the intubation:\n\naspiration pneumonia (new opacity on chest imaging within 48 hours after intubation, in comparison to the first chest imaging after hospital admission), pneumothorax (new air collection within the pleural cavity on chest imaging)'}, {'measure': 'Change of SpO2/FiO2 ratio (pulsed oxygen saturation / fraction of inspired oxygen) between the time of confirmation of correct tube placement and the minimum ratio', 'timeFrame': 'Within one hour after confirmation of correct tube placement', 'description': 'SpO2/FiO2 collected every 10 minutes to determine the minimum ratio'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bougie', 'Intubation', 'Acute Respiratory failure', 'Airway', 'Critical Care'], 'conditions': ['Acute Respiratory Failure Requiring Intubation']}, 'referencesModule': {'references': [{'pmid': '40890804', 'type': 'DERIVED', 'citation': 'Le Bastard Q, Jenvrin J, Gaultier A, Montassier E. Bougie versus endotracheal tube alone on first-attempt intubation success in prehospital emergency intubation in patients without predictors of difficult intubation: protocol for the BETA randomized controlled trial. Trials. 2025 Sep 1;26(1):327. doi: 10.1186/s13063-025-09046-8.'}]}, 'descriptionModule': {'briefSummary': 'Emergency intubation is routinely performed in the prehospital setting. Airway management in the prehospital setting has substantial challenges, such as hostile environment or lack of technical support in case of first attempt intubation failure, and inherent risk of complications, such as hypoxemia, aspiration or oesophageal intubation. This risk is higher when several attempts are needed to succeed endotracheal intubation. Thus, a successful first attempt intubation is highly desirable to avoid adverse intubation-related events. Noteworthy, prehospital emergency intubation is associated with a lower rate of first attempt intubation success when compared to emergency intubation in the emergency department (ED). Research is needed to overcome the specific challenges of airway management in the prehospital setting, and to improve the safety and efficiency of prehospital emergency intubation. Literature reports that the use of assistive devices such as bougie may increase the rate of first-attempt intubation success in the ED. To date, no randomized trial has ever studied this device in the prehospital setting. Thus, the aim of the BETA trial is to compare first attempt intubation success facilitated by the bougie versus the endotracheal tube alone in the prehospital setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Managed by a physician staffed mobile intensive care unit (MICU).\n* With an indication of emergency prehospital endotracheal intubation.\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients with a "not to be resuscitated" indication.\n* Patients with predictors of difficult intubation (that can be collected in the prehospital setting, including previous history of face, neck, throat surgery or pathology, limited mandibular protrusion, cervical spine trauma, facial trauma, ear-nose-throat malignancy, head or neck burns, history of previous difficult airways) for whom the use of a bougie is indicated on first intubation attempt.\n* Patients under guardianship, trusteeship or safeguard of justice and patients with no health insurance.'}, 'identificationModule': {'nctId': 'NCT06307392', 'acronym': 'BETA', 'briefTitle': 'Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation (BETA Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Bougie Versus Endotracheal Tube Alone on First-attempt Intubation Success in Prehospital Emergency Intubation in Patients Without Predictors of Difficult Intubation (BETA Trial)', 'orgStudyIdInfo': {'id': 'RC22_0393'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endotracheal tube plus bougie', 'interventionNames': ['Procedure: First intubation attempt with endotracheal tube plus bougie']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endotracheal tube alone', 'interventionNames': ['Procedure: First intubation attempt with endotracheal tube alone']}], 'interventions': [{'name': 'First intubation attempt with endotracheal tube plus bougie', 'type': 'PROCEDURE', 'description': 'Use of a straight, malleable, semirigid bougie on first-attempt intubation. The required bougie is at least 60cm length, a coudé tip is recommended but not required. Operator may choose whether to bend the bougie prior to intubation.\n\nDuring laryngoscopy, the operator will insert the bougie into the trachea under direct or indirect visual control. If the bougie is successfully placed in the trachea, an assistant will load the endotracheal tube directly over the bougie while the operator will manually stabilize the bougie. Once the bougie has reached the mouth, the assistant will then stabilize the bougie, and the operator will advance the tube through the vocal cords to the adequate depth in the trachea, without removing the laryngoscope from the mouth. The operator will inflate the cuff and manually stabilize the tube. Then, the assistant will withdraw the bougie from the endotracheal tube.\n\nThe use of a stylet is not permitted.', 'armGroupLabels': ['Endotracheal tube plus bougie']}, {'name': 'First intubation attempt with endotracheal tube alone', 'type': 'PROCEDURE', 'description': 'During laryngoscopy, the operator will insert the endotracheal tube alone into the trachea under direct or indirect visual control. The operator will advance the tube through the vocal cords to the adequate depth in the trachea, without removing the laryngoscope from the mouth. The operator will inflate the cuff and manually stabilize the tube.\n\nThe use of a stylet is not permitted.', 'armGroupLabels': ['Endotracheal tube alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'Loire Atlantique', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Quentin Le Bastard, MD', 'role': 'CONTACT', 'email': 'quentin.lebastard@chu-nantes.fr', 'phone': '0240087839'}, {'name': 'Quentin Le Bastard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Quentin LE BASTARD, MD', 'role': 'CONTACT', 'email': 'quentin.lebastard@chu-nantes.fr', 'phone': '0240087839'}], 'overallOfficials': [{'name': 'Quentin LE BASTARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}