Nctid:
NCT06611917
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>110}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-06-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2024-04-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-22", "studyFirstSubmitDate"=>"2024-07-12", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-12-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Effectiveness of Difficult Airway Prediction", "timeFrame"=>"up to one hour", "description"=>"The primary outcome measures the effectiveness of ultrasonography and physical examination in predicting difficult airways in patients undergoing general anesthesia. Occurrence of a difficult airway is the primary outcome. A difficult airway is defined by specific clinical criteria:\n\nMore than two intubation attempts, Intubation time exceeding 10 minutes, or Cormack-Lehane laryngoscopy grade of 3 or 4. Data will be collected during the intubation process. Intubation attempts and time will be recorded by the anesthesiologist, while the Cormack-Lehane grading will be assessed based on the view of the glottis during laryngoscopy.\n\nMeasurement Process:\n\nUltrasonographic measurements of the airway will be taken preoperatively using non-invasive ultrasound techniques. Additionally, physical examination tests will be performed preoperatively to assess airway risk. The outcome is categorized as difficult airway (yes/no) based on whether the patient meets any of the defined criteria."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Airway Management", "Endotracheal Intubation", "Ultrasonography"], "conditions"=>["Airway Complication of Anesthesia"]}, "descriptionModule"=>{"briefSummary"=>"This study evaluates the effectiveness of ultrasonographic measurements compared to traditional physical examination tests in predicting difficult airways. With no definitive gold standard for anticipating airway challenges, this research explores the diagnostic capabilities of newer, non-invasive techniques like ultrasonography-which is gaining popularity due to its ease of use and widespread availability-in the field of anesthesia. The study focuses on defining highly sensitive and easy-to-use ultrasonographic markers that could aid anesthesiologists, intensive care specialists, and emergency physicians in effective airway management.", "detailedDescription"=>"Anesthesiologists, intensive care specialists, and emergency physicians frequently encounter the challenge of managing difficult airways, a critical competency as failure to secure the airway can lead to severe consequences, including brain damage or death. Intubation, a complex procedure involving several anatomical maneuvers, has traditionally relied on physical examination indicators such as dental and facial anatomy, Mallampati score, and neck mobility to predict potential difficulties. However, these methods, while useful, often lack the accuracy needed for reliable prediction, leading to a significant percentage of unexpected difficult intubations.\n\nRecent advances in medical imaging propose the use of radiological and ultrasonographic assessments to enhance predictive accuracy. Ultrasonography, in particular, offers a non-invasive, easily accessible method for examining airway structures, which could potentially transform standard practices in airway management. The American Society of Anesthesiologists recognizes the promising role of ultrasound in airway assessment, yet acknowledges the need for more standardized approaches to its implementation.\n\nThis research aims to compare the predictive value of physical examination findings with that of ultrasonographic measurements such as the distance from skin to hyoid bone, skin to epiglottis, and tongue volume. By establishing more reliable and sensitive ultrasonographic markers, this study seeks to provide clinicians with better tools for assessing the risk of difficult airways, ultimately contributing to safer anesthesia practices and reducing the incidence of intubation-related complications."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"Patients aged 18-60 years undergoing surgery under general anesthesia with an ASA classification of 1-3.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients classified as American Society of Anesthesiologists (ASA) class I-II-III.\n* Individuals aged between 18 and 60 years.\n* Patients scheduled for elective surgery require endotracheal intubation under general anesthesia\n\nExclusion Criteria:\n\n* Patients with pathologies in the airway or head and neck area (masses, cancer, congenital anomalies, acquired anatomical disorders).\n* Individuals with active infections.\n* Those with cervical vertebral damage.\n* Patients with a history of head and neck trauma.\n* Individuals who have undergone previous head and neck surgery.\n* Patients with a history of head and neck radiotherapy.\n* Pregnant individuals.\n* Obese patients (body mass index \\> 30).\n* Non-cooperative patients.\n* Patients are requiring surgery under emergency conditions."}, "identificationModule"=>{"nctId"=>"NCT06611917", "briefTitle"=>"Diagnostic Values of Physical Examination and Ultrasonographic Measurements in Predicting Difficult Airways", "organization"=>{"class"=>"OTHER", "fullName"=>"Çanakkale Onsekiz Mart University"}, "officialTitle"=>"Comparative Diagnostic Values of Physical Examination Tests and Ultrasonographic Measurements in Predicting Difficult Airways", "orgStudyIdInfo"=>{"id"=>"COMU-SBF-AES-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Ultrasonographic and Physical Examination Cohort", "description"=>"Participants in this study are patients scheduled for surgery under general anesthesia. The participants will undergo standard physical examination tests conducted by anesthesiologists before surgery and will also receive ultrasonographic measurements of the subglottic and other critical airway structures. The participants will be categorized as an observational cohort in which the ultrasonographic assessments will be compared with the results of the physical examination. The primary objective of this study is to compare the effectiveness of these two methods in predicting difficult airways."}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"17020", "city"=>"Çanakkale", "state"=>"Merkez", "country"=>"Turkey", "facility"=>"Canakkale Onsekiz Mart University", "geoPoint"=>{"lat"=>40.15552, "lon"=>26.41271}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Çanakkale Onsekiz Mart University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Specialist Doctor", "investigatorFullName"=>"Ayse Ezgi SUBASI", "investigatorAffiliation"=>"Çanakkale Onsekiz Mart University"}}}}
