Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-03 @ 2:56 PM
Study NCT ID:
NCT07493356
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Difficult Airway Prediction by Integrating STOP-BANG Criteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 233}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-09-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-19', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adequate Bag-Mask Ventilation', 'timeFrame': 'Only once, after giving general anesthesia but before an endotracheal tube is put in the trachea', 'description': 'When an anesthetized patient is being manually ventilated by an anesthesia bag and a face mask and achieving a tidal volume of 5 ml/kg, it will be called adequate mask ventilation.\n\n* Easy if a single anesthesiologist achieves visible adequate chest rise and an end-tidal CO₂ graph.\n* Moderately difficult, if there is a slight chest rise, a low end-tidal CO₂ graph, but peripheral oxygen saturation is maintained above 97%.\n* Difficult if there is no visible chest rise, minimal or no end-tidal CO₂ graph, or if peripheral oxygen saturation drops to less than 95% but becomes normal with use of an oral airway (Guedel airway) or a laryngeal mask airway (LMA), or if two anesthesia providers are required for adequate mask ventilation.\n* Very difficult if peripheral oxygen saturation drops to 90% or less despite the use of airway adjuncts (Guedel airway or LMA).'}, {'measure': 'Difficult Tracheal Intubation', 'timeFrame': 'Only once, after giving general anesthesia and 3-minute bag-mask ventilation for adequate muscle relaxation effect, then direct laryngoscopy will be performed to put the endotracheal tube in the trachea', 'description': 'Difficult tracheal intubation will be defined as, one that requires external laryngeal manipulation, laryngoscopy requiring more than 3 attempts at intubation, intubation requiring nonstandard equipment or approaches, or the inability to intubate at all'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laryngoscopy', 'Ventilation of lungs', 'Bag-mask', 'General Anesthesia'], 'conditions': ['Ventilatory Defect', 'Intubation; Difficult or Failed']}, 'descriptionModule': {'briefSummary': 'This study is being done to determine the diagnostic accuracy of the STOP-BANG questionnaire in predicting difficult mask ventilation and intubation among obese patients.\n\nDuring the preoperative assessment, eligible participants will be enrolled in the study. The modified Mallampati score, thyromental distance, mouth opening, and upper lip bite tests will be performed along with STOP-Bang scores.\n\nLater in the operating room, general anesthesia will be given, and bag-mask ventilation and intubation grade will be assessed and recorded. A correlation will be assessed between the difficult airway assessment findings, along with the STOP-BANG score and the bas-mask difficulty scores and intubation grades.', 'detailedDescription': "After approval of the Ethical Review Committee (ERC), the study will commence. Participants will be selected from the scheduled elective surgical lists of all surgical departments. Written informed consent will be acquired from all study participants. The resident will document demographic variables (age, height, weight, and gender) and STOP-Bang scores during the pre-anesthesia assessment for eligible participants. A STOP-Bang score of ≥ 3 will suggest a higher risk for difficult airway, whereas a score of \\< 3 will suggest a lower risk. Anesthesia residents under the supervision of a consultant anesthesiologist will record intraoperative observations on a study form. A qualified anesthesia provider performing bag-mask ventilation must have at least three years of anesthesia experience. The primary investigator will gather the questionnaire and intraoperative data form from the trained anesthesiologist. The anesthesiologist managing the airway will be unaware of the STOP-Bang score. Standard monitoring (ECG, non-invasive blood pressure, and peripheral oxygen saturation) will be attached, and baseline readings will be recorded. Pre-oxygenation will be performed for three minutes. Anesthesia will be induced with nalbuphine 100 micrograms/kg and propofol 2 mg/kg until the patient becomes unresponsive to verbal communication; atracurium 0.6 mg/kg will be given after assessing ventilation. Mask ventilation will be carried out for three minutes with the patient's head in the sniffing position. The supervising consultant will decide when to intervene if the primary anesthetist is unable to mask ventilate the patient.\n\nFollowing three minutes of mask ventilation, the trachea will be intubated using a Macintosh laryngoscope. The endotracheal tube's correct position will be confirmed by monitoring a persistent end-tidal CO₂ waveform, visible chest rise, and bilateral chest auscultation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Male \\& Female aged 18-60 years.\n* Body mass index 30 or more\n* American Society of Anesthesiologists (ASA) status II-III.\n* Scheduled for elective surgery under general anesthesia with endotracheal intubation.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male \\& Female aged 18-60 years.\n* Body mass index 30 or more\n* American Society of Anesthesiologists (ASA) status II-III.\n* Scheduled for elective surgery under general anesthesia with endotracheal intubation.\n\nExclusion Criteria:\n\n* Patients' refusal to participate.\n* American Society of Anesthesiologists (ASA) IV \\& V.\n* Neuromuscular diseases or facial abnormalities.\n* Cardiothoracic, head and neck, or emergency surgery.\n* Previously diagnosed with OSA (by polysomnography) will be excluded.\n* Any airway-related anatomical deformity (e.g., Down's syndrome).\n* History of radiation exposure.\n* Patient with mouth opening \\<2 fingers"}, 'identificationModule': {'nctId': 'NCT07493356', 'briefTitle': 'Difficult Airway Prediction by Integrating STOP-BANG Criteria', 'organization': {'class': 'OTHER', 'fullName': 'Sindh Institute of Urology and Transplantation'}, 'officialTitle': 'Enhancing Difficult Airway Prediction in Obese Patients: Integrating STOP-BANG With Additional Airway Assessment Tools', 'orgStudyIdInfo': {'id': 'SIUT-ERC-2025/A-587'}}, 'contactsLocationsModule': {'locations': [{'zip': '74200', 'city': 'Karachi', 'state': 'Sindh', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Syed M Abbas, FCPS', 'role': 'CONTACT', 'email': 'smabbas69@hotmail.com', 'phone': '+923331318838'}], 'facility': 'Sindh Institute of Urology and Transplantation', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Syed M Abbas, FCPS', 'role': 'CONTACT', 'email': 'smabbas69@hotmail.com', 'phone': '02199215718', 'phoneExt': '2193'}], 'overallOfficials': [{'name': 'Syed M Abbas, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sindh Institute of Urology and Transplantation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sindh Institute of Urology and Transplantation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Syed Muhammad Abbas', 'investigatorAffiliation': 'Sindh Institute of Urology and Transplantation'}}}}