Cardiopulmonary Disease Clinical Trial
— SGA-TEEOfficial title:
Supraglottic Airway Use for Transesophageal Echocardiography: a Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease. (SGA-TEE)
Verified date | June 2024 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 9, 2024 |
Est. primary completion date | March 9, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | Inclusion Criteria: - Adults presenting for elective outpatient TEE examinations at UF Shands hospital during the study duration Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | UF Health Jacksonville | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of successfully completed TEE examinations with the assigned airway intervention | 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. | Duration of procedure | |
Secondary | Ease of Placement of LMA | 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 | Duration of procedure | |
Secondary | Alternative Airway device | 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) | Duration of procedure | |
Secondary | Dislocation of LMA | 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. | Duration of procedure | |
Secondary | Chin Lift or Jaw Thrust | 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. | Duration of Procedure | |
Secondary | Pharyngeal Bleeding | the incidence of pharyngeal bleeding during placement or after the procedure | Duration of Procedure | |
Secondary | Hypoxia | Hypoxia during the procedure will be defined as an oxygen saturation (SpO2) <92% for more than 5 minutes.
Regurgitation defined by visualized gastric contents requiring suctioning Aspiration defined by desaturation after regurgitation with suspicion of the anesthesiologist or CRNA that aspiration occurred. |
Duration of Procedure | |
Secondary | Aspiration | Aspiration will be defined by desaturation (SpO2 <92) after regurgitation and inhalation of the gastric contents. | Duration of Procedure | |
Secondary | Duration of the endoscopic procedure | Insertion to removal of TEE probe | Duration of Procedure | |
Secondary | Sore throat | 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 | Duration of procedure up to 24 hours after the procedure ends. | |
Secondary | Ease and comfort of advancing and operating the Endoscope by attending endoscopist | 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). | Duration of procedure |
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