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Cardiopulmonary DiseaseSGA-TEENCT04939220

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

A study testing TEE with SGA and TEE with Deep Sedation in people with Cardiopulmonary Disease, run by University of Florida at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 yearsHealthy volunteers can take part
Conditions the study is for
Cardiopulmonary Disease
What is being tested?
TEE with SGA and TEE with Deep Sedation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Feb 2024to 9 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UF Health Jacksonville

    Jacksonville, Florida, 32209

Other trials in United States

About this study

Official title: Supraglottic Airway Use for Transesophageal Echocardiography: a Safe Alternative to Deep Sedation for Patients With High-risk Cardiopulmonary Disease. (SGA-TEE)

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.

Read the detailed description

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.

Transesophageal 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.

Moreover, 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.

The 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.

The 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.

Being tested
TEE with SGA, TEE with Deep Sedation
Keywords
TEE, SGA, Anesthesia, sedation, Chronic Hypoxemic lung Disease, Obstructive Sleep Apnea, Morbid Obesity
Medical subject headings
Pulmonary Heart Disease, Sleep Apnea, Obstructive, Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEE with SGAProcedure or surgery

    SGA Placement and maintenance with inhalational anesthetic or propofol

  • TEE with Deep SedationProcedure or surgery

    Deep sedation with propofol and natural airway

Study groups in NCT04939220
Study groupRoleWhat they receive
Control GroupActive comparatorDeep sedation with propofol and natural airway
Receives: Procedure: TEE with Deep Sedation
Experimental GroupExperimentalSGA Placement and maintenance with inhalational anesthetic or propofol
Receives: Procedure: TEE with SGA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Duration of procedure

Secondary outcomes (10)

  1. 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

    Measured: Duration of procedure

  2. 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)

    Measured: Duration of procedure

  3. 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.

    Measured: Duration of procedure

  4. 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.

    Measured: Duration of Procedure

  5. Pharyngeal Bleeding

    the incidence of pharyngeal bleeding during placement or after the procedure

    Measured: Duration of Procedure

  6. 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.

    Measured: Duration of Procedure

  7. Aspiration

    Aspiration will be defined by desaturation (SpO2 <92) after regurgitation and inhalation of the gastric contents.

    Measured: Duration of Procedure

  8. Duration of the endoscopic procedure

    Insertion to removal of TEE probe

    Measured: Duration of Procedure

  9. 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

    Measured: Duration of procedure up to 24 hours after the procedure ends.

  10. 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).

    Measured: Duration of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2021
  2. Study startFeb 2024 (estimated)
  3. Primary completion9 Mar 2024 (estimated)
  4. Study completion9 Mar 2024 (estimated)

Why it stopped: PI unavailable to conduct study or begin recruitment. No longer feasible.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized control trial
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04939220
Sponsor's protocol ID
IRB202101097
Acronym
SGA-TEE
Status last verified
Jun 2024
First submitted
24 May 2021
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31257818

  • 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.

    PubMed 29406183

  • 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.

    PubMed 32404136

  • 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.

    PubMed 32035477

  • 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.

    PubMed 33061677

  • 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.

    PubMed 31149001

  • 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.

    PubMed 20179502

  • 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.

    PubMed 29229253

  • 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.

    PubMed 10589667

  • 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.

    PubMed 12968230

  • 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.

    PubMed 30734949

  • 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.

    PubMed 31101507

Questions about this trial

What is this clinical trial studying?

A study testing TEE with SGA and TEE with Deep Sedation in people with Cardiopulmonary Disease, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of successfully completed TEE examinations with the assigned airway intervention (time frame: Duration of procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04939220, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

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