Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-06 @ 1:53 AM
Study NCT ID:
NCT06661967
Status:
RECRUITING
Last Update Posted:
2024-10-28
First Post:
2024-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Oral Anesthesia Adjuncts in Conventional Intubation on First-Pass Success Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The participants are randomized into two groups. The first group receives lidocaine oral spray during preoxygenation while the latter will receive NSS spray as placebo.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-25', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-10-25', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First-pass success rate', 'timeFrame': '1 Year', 'description': 'Comparison of the succession rate of endotracheal tube intubation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unrecognized Condition']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the first-pass success rate in video laryngoscopy and other parameters that topical anesthesia can affect during intubation.', 'detailedDescription': 'In Thailand, conventional intubation or sedation without paralysis is still the most common method of intubation due to the lack of emergency physicians at primary care centers. A pilot study had shown that topical oral anesthesia can improve the first-pass success rate in conventional intubation by direct laryngoscopy. This study aims to determine the first-pass success rate in video laryngoscopy and other parameters that topical anesthesia can affect during intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in emergency department that have indication for conventional intubation\n* Age \\> 18 yr\n\nExclusion Criteria:\n\n* Patient who undergo RSI\n* Patient who falls in cardiac arrest airway algorithm\n* Patient who is currently pregnancy\n* Known allergy to lidocaine'}, 'identificationModule': {'nctId': 'NCT06661967', 'briefTitle': 'Topical Oral Anesthesia Adjuncts in Conventional Intubation on First-Pass Success Rate', 'organization': {'class': 'OTHER', 'fullName': 'Queen Savang Vadhana Memorial Hospital, Thailand'}, 'officialTitle': 'Topical Oral Anesthesia Adjuncts in Conventional Intubation: A Randomized Controlled Trial Evaluating the Impact of Topical Oral Anesthesia on First-pass Success Rate', 'orgStudyIdInfo': {'id': '017/2567'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine spray', 'description': 'Spray lidocaine 10 puffs at oropharynx during preoxygenation if the patient body weight is lower than 60kg, otherwise 15 puffs', 'interventionNames': ['Drug: Lidocaine spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Spray normal saline 10 puffs at oropharynx during preoxygenation if the patient body weight is lower than 60kg, otherwise 15 puffs', 'interventionNames': ['Drug: Lidocaine spray']}], 'interventions': [{'name': 'Lidocaine spray', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Comparison of the success rate of endotracheal intubations between lidocaine spray and placebo', 'armGroupLabels': ['Lidocaine spray', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20110', 'city': 'Chon Buri', 'state': 'Changwat Chon Buri', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Sila Thammongkol', 'role': 'CONTACT', 'email': 'Sila_th@outlook.com', 'phone': '0853510161'}], 'facility': 'Queen Savang Vadhana Memorial Hospital', 'geoPoint': {'lat': 13.3622, 'lon': 100.98345}}], 'centralContacts': [{'name': 'Sila Thammongkol', 'role': 'CONTACT', 'email': 'Sila_th@outlook.com', 'phone': '0853510161'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Savang Vadhana Memorial Hospital, Thailand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}