SGA for TEE: Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease.

NCT04939220 | Withdrawn

• 1 other identifier: IRB202101097
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiopulmonary Disease

Keywords

TEE; SGA; Anesthesia; sedation; Chronic Hypoxemic lung Disease; Obstructive Sleep Apnea; Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Ease of Placement of LMA

  Duration of procedure

• Alternative Airway device

  Duration of procedure

• Dislocation of LMA

  Duration of procedure

• Chin Lift or Jaw Thrust

  Duration of Procedure

• Pharyngeal Bleeding

  Duration of Procedure

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Deep sedation with propofol and natural airway

Procedure: TEE with Deep Sedation

Experimental Group

EXPERIMENTAL

SGA Placement and maintenance with inhalational anesthetic or propofol

Procedure: TEE with SGA

Interventions

TEE with SGA PROCEDURE

SGA Placement and maintenance with inhalational anesthetic or propofol

Experimental Group

TEE with Deep Sedation PROCEDURE

Deep sedation with propofol and natural airway

Control Group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults presenting for elective outpatient TEE examinations at UF Shands hospital during the study duration

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

Related Publications (12)

• 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: 31257818 BACKGROUND

• 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: 29406183 BACKGROUND

• 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: 32404136 BACKGROUND

• 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: 32035477 BACKGROUND

• 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: 33061677 BACKGROUND

• 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: 31149001 BACKGROUND

• 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: 20179502 BACKGROUND

• 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: 29229253 BACKGROUND

• 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: 10589667 BACKGROUND

• 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: 12968230 BACKGROUND

• 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: 30734949 BACKGROUND

• 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.

  PMID: 31101507 BACKGROUND

Related Links

• Power calculator for binary outcome non-inferiority trial. Sealed Envelope Ltd. 2012. Power calculator for binary outcome non-inferiority trial. \[Online\] \[Accessed Sat Apr 03 2021\].

MeSH Terms

Conditions

Pulmonary Heart Disease; Sleep Apnea, Obstructive; Obesity, Morbid

Interventions

Deep Sedation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Stefan Braunecker, MD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization to control group- deep sedation with propofol and natural airway or Experimental group-SGA Placement and maintenance with inhalational anesthetic or propofol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized control trial

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 25, 2021
• Study Start: February 1, 2024
• Primary Completion: March 9, 2024
• Study Completion: March 9, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)