Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-03 @ 3:03 PM
Study NCT ID:
NCT04939220
Status:
WITHDRAWN
Last Update Posted:
2024-06-21
First Post:
2021-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SGA for TEE: Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011660', 'term': 'Pulmonary Heart Disease'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054810', 'term': 'Deep Sedation'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Randomization to control group- deep sedation with propofol and natural airway or Experimental group-SGA Placement and maintenance with inhalational anesthetic or propofol.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI unavailable to conduct study or begin recruitment. No longer feasible.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-03-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2021-05-24', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of successfully completed TEE examinations with the assigned airway intervention', 'timeFrame': 'Duration of procedure', 'description': 'The primary outcome is a binary data point (yes/no) defined as the success of using the assigned LMA or natural airway successfully for a TEE procedure.'}], 'secondaryOutcomes': [{'measure': 'Ease of Placement of LMA', 'timeFrame': 'Duration of procedure', 'description': 'Defined by placement of LMA on first attempt, with good chest rise on positive pressure assisted ventilation, no audible leak on assisted ventilation with cuff pressure \\<32 cm H2O, and sustained, square waveform capnography'}, {'measure': 'Alternative Airway device', 'timeFrame': 'Duration of procedure', 'description': 'this secondary outcome is a binary data point (yes/no) on the use of an endotracheal tube for rescue from failure of assigned airway type for the procedure (LMA vs natural airway with sedation)'}, {'measure': 'Dislocation of LMA', 'timeFrame': 'Duration of procedure', 'description': 'this secondary outcome is a binary data point (yes/no) for any form of dislocation of the LMA during the endoscopic procedure necessitating repositioning of the LMA.'}, {'measure': 'Chin Lift or Jaw Thrust', 'timeFrame': 'Duration of Procedure', 'description': 'this secondary outcome is a binary data point (yes/no) for the need to perform chin lift or jaw thrust to maintain a patent airway.'}, {'measure': 'Pharyngeal Bleeding', 'timeFrame': 'Duration of Procedure', 'description': 'the incidence of pharyngeal bleeding during placement or after the procedure'}, {'measure': 'Hypoxia', 'timeFrame': 'Duration of Procedure', 'description': 'Hypoxia during the procedure will be defined as an oxygen saturation (SpO2) \\<92% for more than 5 minutes.\n\nRegurgitation defined by visualized gastric contents requiring suctioning Aspiration defined by desaturation after regurgitation with suspicion of the anesthesiologist or CRNA that aspiration occurred.'}, {'measure': 'Aspiration', 'timeFrame': 'Duration of Procedure', 'description': 'Aspiration will be defined by desaturation (SpO2 \\<92) after regurgitation and inhalation of the gastric contents.'}, {'measure': 'Duration of the endoscopic procedure', 'timeFrame': 'Duration of Procedure', 'description': 'Insertion to removal of TEE probe'}, {'measure': 'Sore throat', 'timeFrame': 'Duration of procedure up to 24 hours after the procedure ends.', 'description': 'As described on a numerical rating scale, and at time 0, 2, and 24 hours 0= no sore throat , 1= mild sore throat, 2= moderate sore throat, 3= severe sore throat'}, {'measure': 'Ease and comfort of advancing and operating the Endoscope by attending endoscopist', 'timeFrame': 'Duration of procedure', 'description': 'The comfort of advancing and operating the endoscope rated by the attending endoscopist after the procedure via a 5 point Likert-type scale (0 = not at all satisfied, 1=slightly satisfied, 2=moderately satisfied, 3=very satisfied, 4 = completely satisfied).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TEE', 'SGA', 'Anesthesia', 'sedation', 'Chronic Hypoxemic lung Disease', 'Obstructive Sleep Apnea', 'Morbid Obesity'], 'conditions': ['Cardiopulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '31257818', 'type': 'BACKGROUND', 'citation': 'Chiew WA, Chen Q, Tan LZ. Use of LMAⓇ GastroTM in esophagogastroduodenoscopy and endoscopy. Korean J Anesthesiol. 2019 Dec;72(6):618-619. doi: 10.4097/kja.19163. Epub 2019 Jul 1. No abstract available.'}, {'pmid': '29406183', 'type': 'BACKGROUND', 'citation': 'Terblanche NCS, Middleton C, Choi-Lundberg DL, Skinner M. Efficacy of a new dual channel laryngeal mask airway, the LMA(R)Gastro Airway, for upper gastrointestinal endoscopy: a prospective observational study. Br J Anaesth. 2018 Feb;120(2):353-360. doi: 10.1016/j.bja.2017.11.075. Epub 2017 Dec 1.'}, {'pmid': '32404136', 'type': 'BACKGROUND', 'citation': 'Tran A, Thiruvenkatarajan V, Wahba M, Currie J, Rajbhoj A, van Wijk R, Teo E, Lorenzetti M, Ludbrook G. LMA(R) Gastro Airway for endoscopic retrograde cholangiopancreatography: a retrospective observational analysis. BMC Anesthesiol. 2020 May 13;20(1):113. doi: 10.1186/s12871-020-01019-5.'}, {'pmid': '32035477', 'type': 'BACKGROUND', 'citation': 'Schmutz A, Loeffler T, Schmidt A, Goebel U. LMA Gastro airway is feasible during upper gastrointestinal interventional endoscopic procedures in high risk patients: a single-center observational study. BMC Anesthesiol. 2020 Feb 8;20(1):40. doi: 10.1186/s12871-020-0938-9.'}, {'pmid': '33061677', 'type': 'BACKGROUND', 'citation': 'Hakim M, Bryant J, Miketic R, Williams K, Erdman SH, Shafy SZ, Kim SS, Tobias JD. Clinical Outcomes of a Modified Laryngeal Mask Airway (LMA(R) Gastro Airway) During Esophagogastroduodenoscopy in Children and Adolescents: A Randomized Study. Med Devices (Auckl). 2020 Sep 21;13:277-282. doi: 10.2147/MDER.S272557. eCollection 2020.'}, {'pmid': '31149001', 'type': 'BACKGROUND', 'citation': "Waruingi D, Mung'ayi V, Gisore E, Wanyonyi S. A randomised controlled trial of the effect of laryngeal mask airway manometry on postoperative sore throat in spontaneously breathing adult patients presenting for surgery at a university teaching hospital. Afr Health Sci. 2019 Mar;19(1):1705-1715. doi: 10.4314/ahs.v19i1.47."}, {'pmid': '20179502', 'type': 'BACKGROUND', 'citation': 'Seet E, Yousaf F, Gupta S, Subramanyam R, Wong DT, Chung F. Use of manometry for laryngeal mask airway reduces postoperative pharyngolaryngeal adverse events: a prospective, randomized trial. Anesthesiology. 2010 Mar;112(3):652-7. doi: 10.1097/ALN.0b013e3181cf4346.'}, {'pmid': '29229253', 'type': 'BACKGROUND', 'citation': "Balmforth D, Smith A, Nagore D, Schilling R, O'Brien B. Can Transesophageal Echocardiography Be Performed Safely Using a Laryngeal Mask Airway During Atrial Fibrillation Ablation? J Cardiothorac Vasc Anesth. 2018 Apr;32(2):790-795. doi: 10.1053/j.jvca.2017.10.040. Epub 2017 Nov 2."}, {'pmid': '10589667', 'type': 'BACKGROUND', 'citation': 'Salvi L, Pepi M. Pressure-assisted breathing through a laryngeal mask airway during transesophageal echocardiography. Anesth Analg. 1999 Dec;89(6):1591-2. doi: 10.1097/00000539-199912000-00070. No abstract available.'}, {'pmid': '12968230', 'type': 'BACKGROUND', 'citation': 'Ferson D, Thakar D, Swafford J, Sinha A, Sapire K, Arens J. Use of deep intravenous sedation with propofol and the laryngeal mask airway during transesophageal echocardiography. J Cardiothorac Vasc Anesth. 2003 Aug;17(4):443-6. doi: 10.1016/s1053-0770(03)00147-2.'}, {'pmid': '30734949', 'type': 'BACKGROUND', 'citation': 'Patrick Mayr N, Michel J, Wiesner G, Rumpf PM. Supraglottic airway device use for transoesophageal echocardiography during left atrial appendage occlusion. Anaesthesia. 2019 Mar;74(3):405-406. doi: 10.1111/anae.14597. No abstract available.'}, {'pmid': '31101507', 'type': 'BACKGROUND', 'citation': 'Saxena S, Aminian A, Nahrwold DA, Daper A. LMA Gastro Airway Seen Through the Eyes of a Cardiac Anesthesiologist. J Cardiothorac Vasc Anesth. 2019 Aug;33(8):2365-2366. doi: 10.1053/j.jvca.2019.04.014. Epub 2019 Apr 20. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.sealedenvelope.com/power/binary-noninferior/', 'label': 'Power calculator for binary outcome non-inferiority trial. Sealed Envelope Ltd. 2012. Power calculator for binary outcome non-inferiority trial. \\[Online\\] \\[Accessed Sat Apr 03 2021\\].'}]}, 'descriptionModule': {'briefSummary': 'Increasingly, transesophageal echos (TEEs) are being done on high risk patients. A TEE is a short procedure done with deep sedation, but poses an increased risk of apnea/ hypoxemia in those with pulmonary disease. It is desirable to avoid intubation, which adds risk. Use of supraglottic airway (SGA) may offer an alternative. The investigators hypothesize that TEEs can be done successfully with an SGA in place. The investigators propose a prospective RCT to compare TEE exams done with deep sedation to those done with an SGA.', 'detailedDescription': 'Increasingly, non-operating room anesthesia (NORA) cases are being performed on patients with high risk for needing advanced airway management, ie patients with morbid obesity, chronic hypoxemic lung disease, obstructive sleep apnea.\n\nTransesophageal echocardiography (TEE) exams are one example of this. While a TEE is typically a short, diagnostic procedure done with deep sedation, deep sedation poses an increased risk of hypoventilation and hypoxemia in patients with cardiopulmonary disease. It is desirable to avoid endotracheal intubation for TEE exams, as the procedure is short and can easily be done without muscle relaxation.\n\nMoreover, securing the airway with an endotracheal tube (ETT) is not without significant risk. The use of a supraglottic airway (SGA) may offer an alternative for patients receiving a TEE who are high risk candidates for deep sedation with a natural airway.\n\nThe investigators hypothesize that the TEE procedure can be done successfully, without interruption, with an SGA in place. Our secondary hypothesis is that SGA use in high-risk patients may be safer than deep sedation, as there may be less episodes of hypoventilation and hypoxemia.\n\nThe investigators propose a prospective randomized control trial to compare TEE exams done with deep sedation (control group) to those done with SGA (intervention group). Our primary outcome will be TEE study completion, and secondary outcomes will focus on the safety profile of the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults presenting for elective outpatient TEE examinations at UF Shands hospital during the study duration\n\nExclusion Criteria:\n\n* Known or suspected difficult airway, patient refusal or inability to consent, patients to have emergent or urgent TEE exams, patients considered to have full stomach ie gastroparesis or achalasia'}, 'identificationModule': {'nctId': 'NCT04939220', 'acronym': 'SGA-TEE', 'briefTitle': 'SGA for TEE: Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease.', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Supraglottic Airway Use for Transesophageal Echocardiography: a Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease. (SGA-TEE)', 'orgStudyIdInfo': {'id': 'IRB202101097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Deep sedation with propofol and natural airway', 'interventionNames': ['Procedure: TEE with Deep Sedation']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'SGA Placement and maintenance with inhalational anesthetic or propofol', 'interventionNames': ['Procedure: TEE with SGA']}], 'interventions': [{'name': 'TEE with SGA', 'type': 'PROCEDURE', 'description': 'SGA Placement and maintenance with inhalational anesthetic or propofol', 'armGroupLabels': ['Experimental Group']}, {'name': 'TEE with Deep Sedation', 'type': 'PROCEDURE', 'description': 'Deep sedation with propofol and natural airway', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Stefan Braunecker, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}