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

Status Withdrawn

Clinical 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. 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04939220
Study type	Interventional
Source	University of Florida
Contact
Status	Withdrawn
Phase	N/A
Start date	February 2024
Completion date	March 9, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms