Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT05954533
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HEAVEN CRITERIA vs Modified LEMON Score for Predicting Difficult Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First attempt intubation success rate', 'timeFrame': 'Two hours', 'description': 'First attempt success would be defined as the placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and either a single insertion of an endotracheal tube into the mouth or a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube into the mouth'}, {'measure': 'Physicians assessment of intubation as easy or difficult', 'timeFrame': 'Two hours', 'description': 'Physicians subjective assessment of airway as easy or difficult'}], 'secondaryOutcomes': [{'measure': 'Total attempts of intubation.', 'timeFrame': 'Two hours', 'description': 'Total number of attempts is divided into less than 10 number of attempts, 10 to 100 and \\>100attempts'}, {'measure': 'Which criteria was the most frequent in causing difficult airway among HEAVEN', 'timeFrame': 'Two hours'}, {'measure': 'Measuring if patient had hypotension', 'timeFrame': '2 hours', 'description': 'SBP 100 and 20% decrease from baseline'}, {'measure': 'Measuring if patient had hypertension', 'timeFrame': '2 hours', 'description': 'SBP \\>160 and 20% increase from baseline'}, {'measure': 'Measurement of bradycardia', 'timeFrame': 'Two hours', 'description': 'Adults: HR \\< 40bpm and 20% decrease from baseline Paeds \\<12yrs: \\<60beats/min requiring atropine'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HEAVEN criteria', 'Modified LEMON', 'Difficult airway', 'Prediction tool'], 'conditions': ['Intubation; Difficult or Failed', 'Intubation Complication']}, 'descriptionModule': {'briefSummary': 'Emergency tracheal intubation is a lifesaving procedure frequently performed on critically ill and injured patients in the emergency department (ED). Emergency intubations are more difficult than elective intubations in the operating room setting because of the sicker patient population with a limited physiologic reserve and less controlled setting in the ED. Indeed, the proportion of difficult intubation ranges from 10% to 27% in the ED setting , whereas the rate ranges from 1% to 9% of elective intubation in the anaesthesia setting. Because emerging evidence demonstrates that repeated intubation attempts are associated with an increased risk of adverse events, early recognition of difficulty intubation with a systematic use of rescue methods in ED patients is critical. The commonest airway prediction tool is the LEMON score. In the modified LEMON score "Mallampati" was excluded as it was not a pragmatic assessment in the ED.\n\nExisting difficult airway prediction tools were derived in the elective surgery environment and may not be applicable to emergency airway management. LEMON criteria was designed for preoperative clinical setting.\n\nHence in this study we are observing if HEAVEN (H- Hypoxemia E - extremes of age A - anatomical abnormalities V - vomit/ blood / fluid E - Exsanguination/anaemia N - neck mobility issues) is a better tool for predicting difficult intubatio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from all age groups requiring endotracheal intubation and who gives consent for the study would be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. All patients who undergo an endotracheal intubation in the emergency medicine department and 2. who legally give consent for the study or relatives give consent\n\nExclusion Criteria:\n\n* Patients not consenting for the study or ยท Patients in cardio respiratory arrest'}, 'identificationModule': {'nctId': 'NCT05954533', 'briefTitle': 'HEAVEN CRITERIA vs Modified LEMON Score for Predicting Difficult Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Jubilee Mission Medical College and Research Institute'}, 'officialTitle': 'Cross Sectional Study to Determine Whether HEAVEN CRITERIA is a Better Tool Than Modified LEMON Score for Predicting Difficult Intubation in In-hospital Emergency Airway Management', 'orgStudyIdInfo': {'id': '39/22/IEC/JMMC&RI'}}, 'contactsLocationsModule': {'locations': [{'zip': '680005', 'city': 'Thrissur', 'state': 'Kerala', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'DR APPU SUSEEL, MBBS,MD', 'role': 'CONTACT', 'email': 'appuariyedath@gmail.com', 'phone': '9847749706'}, {'name': 'DR SIJU V ABRAHAM, MBBS,MD', 'role': 'CONTACT', 'email': 'sijuvabraham@gmail.com', 'phone': '9447754321'}], 'facility': 'JMMCRI', 'geoPoint': {'lat': 10.51667, 'lon': 76.21667}}], 'centralContacts': [{'name': 'JAISMOL JAMES, MBBS', 'role': 'CONTACT', 'email': 'jaismoljames.16@gmail.com', 'phone': '91 9496660433'}, {'name': 'Dr. APPU SUSEEL, MBBS, MD', 'role': 'CONTACT', 'email': 'appuariyedath@gmail.com', 'phone': '91 9847749706'}], 'overallOfficials': [{'name': 'DR APPU SUSEEL, MBBS,MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'JMMCRI'}, {'name': 'DR SIJU V ABRAHAM, MBBS,MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'JMMCRI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jubilee Mission Medical College and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Junior Resident', 'investigatorFullName': 'Dr Jaismol James', 'investigatorAffiliation': 'Jubilee Mission Medical College and Research Institute'}}}}