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SGA vs Deep Sedation for TEE in Cardiopulmonary Diseases (SGA-TEE Trial)
N/A
Waitlist Available
Led By Stefan Braunecker, MD, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of procedure
Awards & highlights
SGA-TEE Trial Summary
This trial will compare the safety of doing a TEE with deep sedation versus an SGA in place.
Who is the study for?
This trial is for adults needing an elective outpatient TEE at UF Shands hospital. It's not for those with difficult airways, who can't consent, need urgent TEEs, or have conditions like gastroparesis affecting stomach emptying.Check my eligibility
What is being tested?
The study compares two ways to do a heart exam called TEE on patients with serious lung/heart disease: one uses deep sedation and the other uses a device called SGA to keep airways open without full sedation.See study design
What are the potential side effects?
Deep sedation may cause breathing problems or low oxygen levels during the procedure. The use of SGA might lead to discomfort in the throat or rarely, minor airway injuries.
SGA-TEE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of successfully completed TEE examinations with the assigned airway intervention
Secondary outcome measures
Alternative Airway device
Aspiration
Chin Lift or Jaw Thrust
+7 moreSGA-TEE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental GroupExperimental Treatment1 Intervention
SGA Placement and maintenance with inhalational anesthetic or propofol
Group II: Control GroupActive Control1 Intervention
Deep sedation with propofol and natural airway
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,595 Total Patients Enrolled
Stefan Braunecker, MD, PhDPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that slows my stomach emptying.I am unable or unwilling to give consent for treatment.I need an immediate or very soon heart ultrasound.Adults coming for planned heart exams at UF Shands hospital during the study.You have a known or suspected problem with your breathing passages.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Experimental Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly individuals being accepted as participants in this experiment?
"This trial is available to individuals who are of legal age or younger than 120 years old."
Answered by AI
What are the criteria for acceptance into this medical trial?
"To qualify for participation in this trial, potential candidates must have a cardio-pulmonary illness and be between 18 and 120 years old. The total number of patients to enroll is estimated at 110 individuals."
Answered by AI
Is enrollment in the trial still open to potential participants?
"Clinicaltrials.gov reveals that this medical trial is no longer recruiting patients, as the last update was in November of 2022 and it initially posted on January 1st 2023. However, there are presently five other clinical trials taking new participants at this time."
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