Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT06677567
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-08
First Post:
2024-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Air-Q and Proseal Laryngeal Mask in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010612', 'term': 'Pharyngitis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2024-11-05', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ease of LMA placement', 'timeFrame': '3 minutes after induction of anesthesia', 'description': 'he ease of LMA placement will be scored by the anesthesiologist on a scale from 1 to 4 (1: Successful on the first attempt with no resistance from the tissues; 2: Successful on the first attempt but with some tissue resistance during placement; 3: Moderate tissue resistance; 4: Failure to place the LMA).'}, {'measure': 'maneuvers required for successful ventilation', 'timeFrame': '3 minutes after induction of anesthesia', 'description': 'It will be recorded whether any further maneuvers are required: Gentle pushing or pulling of the LMA to adjust its depth, jaw-thrust maneuver, and flexion or extension of the head.'}, {'measure': 'fiberoptic view grading', 'timeFrame': '3 minutes after induction of anesthesia', 'description': 'The Brimacombe score will be used to evaluate the view obtained with fiberoptic bronchoscopy. 1: Vocal cords are not visible; 2: Vocal cords and anterior epiglottis are visible; 3: Vocal cords and posterior epiglottis are visible; 4: Vocal cords are visible.'}, {'measure': 'Complications during SP_Air-Q and propseal LMA removal (emerge)', 'timeFrame': 'One minute after SP Air-Q removal', 'description': 'Complications during SP\\_Air-Q and proseal LMA removal (emerge) such as breath-holding during emergence, airway obstruction, coughing, hypoxia (SpO2 \\< 90%), vomiting, lip-tongue-teeth trauma, and bleeding, will be recorded.'}, {'measure': 'Sore throat', 'timeFrame': '1 hours postoperatively', 'description': 'The presence or absence of sore throat will be recorded at the firsth postoperative hour.'}, {'measure': 'Sore throat', 'timeFrame': '24 hours postoperatively', 'description': 'The presence or absence of sore throat will be recorded at the 24th postoperative hour'}, {'measure': 'dysphonia', 'timeFrame': '1 hours postoperatively', 'description': 'The presence or absence of dysphonia will be recorded at the firsth postoperative hour'}, {'measure': 'dysphonia', 'timeFrame': '24 hours postoperatively', 'description': 'The presence or absence of dysphonia will be recorded at the 24th postoperative hour.'}], 'primaryOutcomes': [{'measure': 'Measurement of oropharyngeal leak pressure (OLP)', 'timeFrame': 'One minute after successful LMA placement', 'description': 'One minute after successful LMA placement and fixation, oropharyngeal leak pressure (OLP) will be measured by setting the adjustable pressure limiting valve (APL) to 40 mmHg and maintaining a fresh gas flow of 3 L/min. The OLP will be recorded as the pressure at which an audible leak sound is heard from the mouth.'}], 'secondaryOutcomes': [{'measure': 'SP Air-Q and proseal LMA insertion time', 'timeFrame': '3 minutes after induction of anesthesia', 'description': 'Successful LMA placement will be confirmed by visualizing a square waveform on the ventilator and observing chest wall movement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Air-Q Laryngeal İntubating Airway', 'Oropharyngeal leak pressure', 'proseal larygeal mask', 'supraglottic airways'], 'conditions': ['Postoperative Complications', 'Sore Throat']}, 'referencesModule': {'references': [{'pmid': '26634080', 'type': 'BACKGROUND', 'citation': 'Kim EM, Kim MS, Koo BN, Lee JR, Lee YS, Lee JH. Clinical efficacy of the classic laryngeal mask airway in elderly patients: a comparison with young adult patients. Korean J Anesthesiol. 2015 Dec;68(6):568-74. doi: 10.4097/kjae.2015.68.6.568. Epub 2015 Nov 25.'}, {'pmid': '30343563', 'type': 'RESULT', 'citation': 'In CB, Cho SA, Lee SJ, Sung TY, Cho CK. Comparison of the clinical performance of airway management with the i-gel(R) and laryngeal mask airway SupremeTM in geriatric patients: a prospective and randomized study. Korean J Anesthesiol. 2019 Feb;72(1):39-46. doi: 10.4097/kja.d.18.00121. Epub 2018 Oct 22.'}, {'pmid': '30320644', 'type': 'RESULT', 'citation': 'Lee JS, Kim DH, Choi SH, Ha SH, Kim S, Kim MS. Prospective, Randomized Comparison of the i-gel and the Self-Pressurized air-Q Intubating Laryngeal Airway in Elderly Anesthetized Patients. Anesth Analg. 2020 Feb;130(2):480-487. doi: 10.1213/ANE.0000000000003849.'}, {'pmid': '34092859', 'type': 'RESULT', 'citation': 'Wahba RM, Ragaei MZ, Metry AA, Nakhla GM. Supraglottic Airway Devices for Elective Pediatric Anesthesia: I-gel versus Air-Q, Which is the Best? Anesth Essays Res. 2020 Jul-Sep;14(3):461-466. doi: 10.4103/aer.AER_107_20. Epub 2021 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'Aged- related changes in upper airway anatomy may affect the overall performance of supraglottic airways significantly. In this study, investigator aim to compare the clinical performance, efficacy, and associated complications of the Proseal Laryngeal Mask and the Air-Q Intubation Laryngeal Airway in elderly patients.', 'detailedDescription': 'Elderly patients are vulnerable to perioperative pulmonary complications during intubation and extubation. Supraglottic airway devices (SADs) have been utilized as a relatively easy method of airway management for resuscitation and difficult intubations and are used during elective general anesthesia with reduced airway complications compared to endotracheal intubation. SADs may help maintain hemodynamic stability as they require less anesthetic agents compared to endotracheal intubation. With aging, parapharyngeal fat accumulation increases, leading to pharyngeal collapse in elderly patients. Additionally, structural changes in the respiratory tract combined with physiological alterations in respiration may reduce oxygen saturation, blunt the hypoxic response, and increase postoperative respiratory complications. Acquired changes in pharyngeal muscle activity with age are thought to increase the likelihood of bony structural changes, such as retrognathia, which is typically considered a difficult airway. Therefore, these age-related changes may impact the clinical performance of SADs. ProSeal LMA is one of the most commonly used supraglottic airway devices in clinical practice. It was developed by modifying the classic LMA in the 2000s and features an inflatable cuff. Additionally, it has a gastric channel for gastric aspiration adjacent to the airway tube. Recently, SGAs (supraglottic airways) that do not require manual cuff inflation have been increasingly used in various clinical situations due to the advantages of eliminating manual cuff inflation and monitoring cuff pressure. Air-Q connects to an airway tube via a communication port that allows self-regulation of cuff pressure in response to airway pressure. In this study, investigator aim to compare the clinical performance, efficacy, and associated complications of the Proseal Laryngeal Mask and the Air-Q Intubation Laryngeal Airway in elderly patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 65 to 90 years, both male and female, classified as ASA 1-3, will be included in the study if they undergo surgery with ProSeal LMA and Air-Q intubating airway.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65-90 year-old patients\n* American Society of Anesthesiologist Physical Status classification I-III,\n* Undergoing an elective operation under general anesthesia in our hospital\n\nExclusion Criteria:\n\n* Predicted difficult airway (Mallampati class 4, mouth opening \\< 3 cm, or thyromental distance \\< 6 cm)\n* body mass index (BMI) \\> 40 kg/m2\n* Patients with a high risk of aspiration (e.g., history of gastrectomy, -gastroesophageal reflux disease, or hiatal hernia),\n* Unstable vital signs\n* Cervical spine problems, Respiratory complications (e.g. recent pneumonia).'}, 'identificationModule': {'nctId': 'NCT06677567', 'briefTitle': 'Air-Q and Proseal Laryngeal Mask in Elderly Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Diskapi Yildirim Beyazit Education and Research Hospital'}, 'officialTitle': 'Comparison of the Efficacy of Self-Pressurizing Air-Q Intubation Laryngeal Airway and Proseal Laryngeal Mask in Elderly Patients', 'orgStudyIdInfo': {'id': 'ZeynepKoc003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SP AİR Q group', 'description': 'under general anesthesia, patients inserted Air- Q intubating airway.', 'interventionNames': ['Other: Air-Q Intubating Airway']}, {'label': 'Proseal Group', 'description': 'under general anesthesia, patients inserted proseal laryngeal mask.', 'interventionNames': ['Other: proseal laryngeal mask']}], 'interventions': [{'name': 'Air-Q Intubating Airway', 'type': 'OTHER', 'description': 'Patients will be inserted Air-Q Intubating Airway under general anesthesia', 'armGroupLabels': ['SP AİR Q group']}, {'name': 'proseal laryngeal mask', 'type': 'OTHER', 'description': 'Patients will be inserted proseal laryngeal mask under general anesthesia.', 'armGroupLabels': ['Proseal Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yenimahalle', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Zeynep Koç', 'geoPoint': {'lat': 39.97787, 'lon': 32.80147}}], 'centralContacts': [{'name': 'Zeynep Koc', 'role': 'CONTACT', 'email': 'zeynepyilmazkoc@hotmail.com', 'phone': '+905345958843'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Yildirim Beyazit Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Zeynep Koc', 'investigatorAffiliation': 'Diskapi Yildirim Beyazit Education and Research Hospital'}}}}