Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT04509960
Status:
UNKNOWN
Last Update Posted:
2021-01-05
First Post:
2020-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Ways of Airway Management in Elective Minor Surgeries in Geriatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-04', 'studyFirstSubmitDate': '2020-06-13', 'studyFirstSubmitQcDate': '2020-08-10', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'laryngeal mask placement', 'timeFrame': 'First minute after laryngeal mask insertio', 'description': 'To evaluate the best fiberoptic bronchoscopic view while insertion of pro-Seal laryngeal mask either in a classic way, or with the help of laryngoscope. The fibreoptic evaluation Includes 4, only vocal cords visible; 3, vocal cords plus posterior epiglottis visible 2, vocal cords plus anterior epiglottis visible\n\n; 1, vocal cords not seen.'}, {'measure': 'complications of laryngeal mask insertion', 'timeFrame': 'Complications will be evaluated within 1 hour after patient recovery.', 'description': 'complications like sore throat, hoarseness, nausea, and vomiting or Bloodstain on the laryngeal mask.\n\nwe simply asked patients about them'}], 'secondaryOutcomes': [{'measure': 'hemodynamic response', 'timeFrame': 'Before putting on the Layngeal mask, it will record in beats / minute at 5 minutes for 1 minute and 20 minutes after wearing', 'description': 'Heart rate will record before LMA and post LMA used at first minute'}, {'measure': 'insertion time', 'timeFrame': 'The investigator will record the insertion time in seconds from the moment the laryngeal mask airway passes the incisors until the end-tidal CO2 is visible.', 'description': 'Insertion time was defined from the time of removal of the facemask to the time of the appearance of first capnography upstroke. we assessed this outcome stopwatch'}, {'measure': 'respiratory dynamics', 'timeFrame': 'The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute', 'description': 'The investigator will record the (tidal volume(ml) value from the mechanical ventilator after wearing the laryngeal mask.'}, {'measure': 'hemodynamic responce', 'timeFrame': 'Before putting on the Layngeal mask, it will record in mm Hg at 5 minutes for 1 minute and 20 minutes after wearing', 'description': 'mean blood pressure will record before LMA and post LMA used at first minute'}, {'measure': 'oxygen saturation', 'timeFrame': 'Before putting on the Layngeal mask, it will record in %SpO2 at 5 minutes for 1 minute and 20 minutes after wearing', 'description': 'saturation will record before LMA and post LMA used at first minute'}, {'measure': 'respiratory dynamics', 'timeFrame': 'The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute', 'description': 'The investigator will record the peak airway pressure (cmH2O) value from the mechanical ventilator after wearing the laryngeal mask.'}, {'measure': 'respiratory dynamics', 'timeFrame': 'The first minute after the laryngeal mask insertion, and every 5 minutes thereafter up to the 20th minute', 'description': 'The investigator will record the end-tidal CO2(mmHg) value from the mechanical ventilator after wearing the laryngeal mask.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laryngeal mask'], 'conditions': ['Comparison of Different Laryngeal Mask Wearing Methods']}, 'referencesModule': {'references': [{'pmid': '23139483', 'type': 'BACKGROUND', 'citation': 'Chandan SN, Sharma SM, Raveendra US, Rajendra Prasad B. Fiberoptic assessment of laryngeal mask airway placement: a comparison of blind insertion and insertion with the use of a laryngoscope. J Maxillofac Oral Surg. 2009 Jun;8(2):95-8. doi: 10.1007/s12663-009-0025-8. Epub 2009 Aug 11.'}, {'pmid': '30611202', 'type': 'BACKGROUND', 'citation': 'Kim GW, Kim JY, Kim SJ, Moon YR, Park EJ, Park SY. Conditions for laryngeal mask airway placement in terms of oropharyngeal leak pressure: a comparison between blind insertion and laryngoscope-guided insertion. BMC Anesthesiol. 2019 Jan 5;19(1):4. doi: 10.1186/s12871-018-0674-6.'}, {'pmid': '22686571', 'type': 'BACKGROUND', 'citation': 'Choo CY, Koay CK, Yoong CS. A randomised controlled trial comparing two insertion techniques for the Laryngeal Mask Airway Flexible in patients undergoing dental surgery. Anaesthesia. 2012 Sep;67(9):986-90. doi: 10.1111/j.1365-2044.2012.07167.x. Epub 2012 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'different ways of airway management in elective minor surgeries of geriatric patients', 'detailedDescription': 'The investigators will used two different ways of pro-seal laryngeal mask insertion technique (laryngoscopy- guided technique or the standard technique) in elective minor surgeries of geriatric toothless patients.\n\nThe investigators will record the respiratory dynamics, heartbeat, systolic, diastolic, mean arterial pressures every 5 minutes during surgery. The investigators will record the laryngeal mask insertion time and oropharyngeal leakage pressure. The investigators will evaluate the placement of a laryngeal mask according to young criteria. The development and severity of coughing, retching, laryngospasm, extremity, and head movement during laryngeal mask placement will be recorded. Bloodstains, sore throat, hoarseness will be recorded on the mask that may develop due to laryngeal mask placement. The investigators will use the Briacombe scoring and Campbell category system to assess the position of laryngeal mask airway devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA physical status I or II or III\n2. Who were scheduled to minor elective ambulatory surgery (e.g. urology operations)\n3. Patients undergoing general anesthesia\n4. Those who are planned to wear a laryngeal mask for surgical procedure\n\nExclusion Criteria:\n\n1. patients with full stomach\n2. A history of gastric reflux\n3. A history of convulsions, cardiovascular or neuromuscular disease\n4. Allergies to the study drugs\n5. obese (Body mass index (BMI) ≥ 40 kg / m2)\n6. suspected difficult airway and hyper-reactive airway disease'}, 'identificationModule': {'nctId': 'NCT04509960', 'briefTitle': 'Different Ways of Airway Management in Elective Minor Surgeries in Geriatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ankara Diskapi Training and Research Hospital'}, 'officialTitle': 'Comparison of Airway Placement Conditions and Postoperative Effects of Laryngoscope-guided Laryngeal Mask Placement Methods in Sniffing Position in Geriatric Edentulous Patients', 'orgStudyIdInfo': {'id': 'LMA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'proseal laryngeal mask insertion', 'description': 'no intervention'}, {'type': 'EXPERIMENTAL', 'label': 'proseal laryngeal mask insertion with laryngoscope', 'description': 'with the help of direct laryngoscopy', 'interventionNames': ['Device: direct laryngoskopy']}], 'interventions': [{'name': 'direct laryngoskopy', 'type': 'DEVICE', 'description': 'Proseal Laryngeal mask inserted with direct laryngoskopy', 'armGroupLabels': ['proseal laryngeal mask insertion with laryngoscope']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Siences Diskapi Yildirim Beyazit T&R hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Filiz Akaslan', 'role': 'CONTACT', 'email': 'flz_karaca@hotmail.com', 'phone': '03125962553'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Diskapi Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'specialist', 'investigatorFullName': 'Filiz Akaslan', 'investigatorAffiliation': 'Ankara Diskapi Training and Research Hospital'}}}}