Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT03960567
Status:
COMPLETED
Last Update Posted:
2019-12-27
First Post:
2019-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Accuracy of the POGO Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007818', 'term': 'Laryngeal Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-26', 'studyFirstSubmitDate': '2019-05-21', 'studyFirstSubmitQcDate': '2019-05-21', 'lastUpdatePostDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentile of glottic opening', 'timeFrame': '2 minutes after induction of anesthesia', 'description': 'A percentile of glottic opening score of 100% accounts for full visualization of the larynx starting from anterior commissure to the posterior cartilage, while 0% indicated a complete absence of glottic opening.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intubation', 'Laryngeal view', 'Scoring systems', 'Larynx'], 'conditions': ['Intubation']}, 'referencesModule': {'references': [{'pmid': '10023271', 'type': 'BACKGROUND', 'citation': 'Yentis SM, Lee DJ. Evaluation of an improved scoring system for the grading of direct laryngoscopy. Anaesthesia. 1998 Nov;53(11):1041-4. doi: 10.1046/j.1365-2044.1998.00605.x.'}, {'pmid': '27251753', 'type': 'BACKGROUND', 'citation': 'Norris A, Heidegger T. Limitations of videolaryngoscopy. Br J Anaesth. 2016 Aug;117(2):148-50. doi: 10.1093/bja/aew122. Epub 2016 Jun 1. No abstract available.'}, {'pmid': '10522589', 'type': 'BACKGROUND', 'citation': 'Ochroch EA, Hollander JE, Kush S, Shofer FS, Levitan RM. Assessment of laryngeal view: percentage of glottic opening score vs Cormack and Lehane grading. Can J Anaesth. 1999 Oct;46(10):987-90. doi: 10.1007/BF03013137.'}, {'pmid': '1054169', 'type': 'BACKGROUND', 'citation': 'Roznovan VK. [Condition of oxidation-reduction processes in patients with chronic osteomyelitis of the jaw and phlegmons of the maxillofacial area in connection with surgical intervention and anesthesia]. Stomatologiia (Mosk). 1975 Jan-Feb;54(1):33-6. No abstract available. Russian.'}, {'pmid': '10995154', 'type': 'BACKGROUND', 'citation': 'Cook TM. A grading system for direct laryngoscopy. Anaesthesia. 1999 May;54(5):496-7. doi: 10.1046/j.1365-2044.1999.0907f.x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'A classification method describing the larynx appearance during laryngoscopy accepted by all anesthetists has not been defined yet. In one study, it was shown that anesthetists mis classed the glottis image by 50%. The most commonly used classification method is the Cormack Lehane (CL) classification. This classification classifies the larynx appearance during direct laryngoscopy form 1 to 4. The modified CL classification is criticized as it does not predict difficult intubation and especially grade 2 is operator dependent and partial view is not well defined. The numerical expression of the percentage of the glottic aperture (POGO = percentile of glottic opening) is another score. In this score, A POGO score of 100% accounts for full visualization of the larynx starting from anterior commissure to the posterior cartilage, while 0% indicated a complete absence of glottic opening.\n\nThe use of a standard and effective classification method will facilitate and accelerate communication between anesthetists in difficult life-threatening situations such as difficult airway / difficult intubation / difficult ventilation and contribute to patient safety. The use of common terminology can also facilitate the evaluation of the performance of intubation tools.\n\nThe aim of this study was to evaluate the accuracy and intra and inter rater reliability of the POGO score.', 'detailedDescription': 'Anesthesiologist will be asked to score still images of laryngeal views, which will be obtained from patients requiring intubation for general anesthesia, after obtaining written informed consent.\n\nThe images of the larynx will be captured first with the Macintosh blade and thereafter with the D blade. A group of independent anesthesiologist will score these images with the Cormack Lehane and POGO scores. The set of images will be prepared from patients with both difficult and normal airway anatomy. Some images in the series will be repeated to assess intra rater variability.\n\nThe anesthesiologist will be asked to rate 20 images both with the CL and POGO scores.\n\nThe experience of the raters in airway management, their experience with videolaryngoscopy and scoring systems used currently when documenting videolaryngoscopy and demographic data will be also obtained.\n\nThe POGO scores of the participants and investigators will be compared.\n\nThe outcome of interest is the correct POGO score rate of the participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing surgery and those who are intubated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving general anesthesia\n\nExclusion Criteria:\n\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT03960567', 'briefTitle': 'Evaluation of the Accuracy of the POGO Score', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'Evaluation of the Accuracy and the Intra and Inter Rater Reliability of the POGO Score', 'orgStudyIdInfo': {'id': 'POGO'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Videolaryngoscopy', 'type': 'DEVICE', 'description': 'Patient will be intubated by using videolaryngoscope'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06300', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Dilek Ünal', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Dilek Ünal, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Netherlands: Ministry of Health, Welfare and Sports'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof', 'investigatorFullName': 'DILEK YAZICIOGLU', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}