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

NCT04939220 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-06-21

No results posted yet for this study

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

Interventions

PROCEDURE

TEE with SGA

SGA Placement and maintenance with inhalational anesthetic or propofol

PROCEDURE

TEE with Deep Sedation

Deep sedation with propofol and natural airway

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Stefan Braunecker, MD, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2024-03-09
Completion
2024-03-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04939220 on ClinicalTrials.gov