Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT07255235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between C-mac,Pentax Video Laryngoscopes and Machintosh Laryngoscope
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': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of first pass of orotracheal intubation', 'timeFrame': 'Untill the end of the study in average of 1 year', 'description': 'Passage of the orotracheal tube from the first time confirmed By capnography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation; Difficult or Failed']}, 'referencesModule': {'references': [{'pmid': '38104962', 'type': 'RESULT', 'citation': 'Taboada M, Almeida X, Carinena A, Costa J, Carmona-Monge J, Agilda A, Barreiro L, Castillo J, Williams K, Segurola J, Alvarez J, Seoane-Pillado T. Complications and degree of difficulty of orotracheal intubation in the Intensive Care Unit before and after the establishment of an intubation protocol for critically ill patients: a prospective, observational study. Rev Esp Anestesiol Reanim (Engl Ed). 2024 Jan;71(1):17-27. doi: 10.1016/j.redare.2023.12.004. Epub 2023 Dec 15.'}, {'pmid': '34188630', 'type': 'RESULT', 'citation': 'Vig S, Bhan S, Gupta N, Meena JK, Bhatnagar S. Comparison of Mc Grath-MAC and C-MAC video laryngoscopes for intubation in a COVID simulated mannequin by novice users wearing face protective gear: A randomized crossover trial. Saudi J Anaesth. 2021 Apr-Jun;15(2):131-136. doi: 10.4103/sja.sja_1058_20. Epub 2021 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'Asses and compare the practility and the level of difficulty in using C-mac and pentax video-laryngoscopes or the traditional Macintoch laryngoscope in intubation in ICU patients while wearing face shield', 'detailedDescription': 'The endotracheal intubation will be performed with anesthesiologist working in ICU previously trained and experienced in videolaryngoscopy and will be classified according to their skill into 3 groups: Junior (1 year up to 3 year) senior, (3 year up to 8 years) and consultant (more than 8 years) experience. All the laryngoscopist groups will equally attend in performing intubation of the studied group. After the patient consent, the allocation will be opened and preparation for intubation will start. All the intubations will be performed with the presence of two laryngoscopist: one of them at least senior or consultant. After confirmation of well working standard monitoring (ECG, blood pressure, Spo2 and End-tidal CO2) and preoxygenation with 100% oxygen, induction with propofol (1-2 mg/kg) and rocuronium (0.9 mg/kg) will be achieved by an assistant.\n\nWhile wearing head-fitted face shield, the anesthetist will perform intubation with suitable sized laryngoscopy blade and endotracheal tube. Successful placement of ETT will be confirmed by both auscaltation and capnography (normal appearing waveform over four or more breathing cycles). During endotracheal intubation, anesthesiologists will be permitted to make ergonomic adjustments, such as altering the bed height, position of the patient head and utilize external laryngeal manipulations, equipment adjustment and use of stylet based on their personal preferences. After three failed attempts of intubation, alternative techniques will be used and subsequently, they will not be included in the analysis. Alternative techniques such as gum elastic bougie, laryngeal mask airway (LMA), Cricothyrotomy set will be ready to any unexpected difficult airway. An intubation attempt is defined as introduction of laryngoscope and its subsequent removal with or without endotracheal tube (ETT) placement. Correct placement of ETT in first attempt by an individual laryngoscopist will be defined as first-pass successful intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients between age 18 - 65 year who will need elective orotracheal intubation will be included in the study after collection of data relevant to intubation except:\n\n* Patients with BMI \\> 35.\n* Pregnant and lactating patients.\n* Burn and facial trauma patients.\n* Suspected or confirmed spine injury.\n* Presence of any predictors or history of difficult intubation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients between age 18 - 65 year who will need elective orotracheal intubation will be included in the study after collection of data relevant to intubation\n\nExclusion Criteria:\n\n* • Patients with BMI \\> 35.\n\n * Pregnant and lactating patients.\n * Burn and facial trauma patients.\n * Suspected or confirmed spine injury.\n * Presence of any predictors or history of difficult intubation.'}, 'identificationModule': {'nctId': 'NCT07255235', 'briefTitle': 'Comparison Between C-mac,Pentax Video Laryngoscopes and Machintosh Laryngoscope', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Comparative Evaluation of C-Mac, Pentax Video Laryngoscopes, and Macintosh Laryngoscope in Endotracheal Intubation in Intensive Care Unit Wearing a Face Shield.', 'orgStudyIdInfo': {'id': '1463'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'C-mac video laryngoscope group', 'description': 'Endotracheal intubation will be performed using the C-Mac video laryngoscope under ICU conditions, while wearing a face shield. The procedure aims to assess time to intubation, ease of use, and success rate.'}, {'label': 'Pentax video-laryngoscope group', 'description': 'Endotracheal intubation will be performed using the Pentax video laryngoscope under ICU conditions, while wearing a face shield. The procedure aims to assess time to intubation, ease of use, and success rate.'}, {'label': 'Machintosh laryngoscope group', 'description': 'Endotracheal intubation will be performed using the traditional Macintosh laryngoscope under ICU conditions, while wearing a face shield. The procedure aims to assess time to intubation, ease of use, and success rate.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '61511', 'city': 'Ma‘şarat Samālūţ', 'state': 'Minya Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Dr omyma S Professor and head of department of Anesthesia', 'role': 'CONTACT', 'email': 'mahmoudmai481@gmail.com', 'phone': '+201061762894'}, {'name': 'Mai M Mohamed Ali', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of Medicine Minia University', 'geoPoint': {'lat': 28.31667, 'lon': 30.71667}}], 'centralContacts': [{'name': 'Mai M Mohamed Ali Mosa', 'role': 'CONTACT', 'email': 'mahmoudmai481@gmail.com', 'phone': '+201000543376'}], 'overallOfficials': [{'name': 'Mai M Mohamed Ali', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Mai Mahmoud Mohamed Ali Mosa', 'investigatorAffiliation': 'Minia University'}}}}