Comparing two types of anesthesia for heart valve replacement procedures
A Randomized Controlled Trial Comparing Monitored Anesthesia Care Versus General Anesthesia With Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement
NA · Medical University of South Carolina · NCT04107038
This study is testing whether using monitored anesthesia care or general anesthesia during heart valve replacement can affect how long patients stay in the hospital and their overall outcomes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina (other) |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT04107038 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) on hospital stay duration, ICU admission rates, and procedural mortality in patients undergoing Transcatheter Aortic Valve Replacement (TAVR). The research aims to determine if the use of Transesophageal Echocardiography (TEE) during GETA influences the success of the device. Eligible participants include adults undergoing transfemoral TAVR for aortic valve stenosis who can safely receive both types of anesthesia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing transfemoral TAVR for aortic valve stenosis who are medically eligible for both MAC and GETA.
Not a fit: Patients who may not benefit include those with contraindications to either anesthetic, pregnant women, and individuals with certain esophageal conditions.
Why it matters
Potential benefit: If successful, this study could lead to improved anesthesia practices that enhance patient outcomes and reduce hospital stays for TAVR procedures.
How similar studies have performed: Other studies have explored anesthesia methods in cardiac procedures, showing varying degrees of success, but this specific comparison is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients ≥ 18 years old * Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis * Adult patients who are medically eligible to receive both anesthetics (GA and MAC) Exclusion Criteria: * Inability to speak English * Body Mass Index (BMI) \> 37 kg/m2 * History of difficult airway requiring fiberoptic intubation * Inability to lie flat * Women who are pregnant * Patients who have contraindications to either anesthetic, such as an allergy or history of malignant hyperthermia, will also be excluded from the study. * Inability or unwillingness of subject to give informed consent based on any reason * Patients with any of the following absolute contraindications to TEE: * Perforated Viscus * Esophageal Stricture * Esophageal Tumor * Esophageal Perforation * Esophageal Diverticulum * Active upper GI Bleed
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: George Whitener, M.D. — Medical University of South Carolina - Department of Anesthesia
- Study coordinator: George Whitener, M.D.
- Email: whiteneg@musc.edu
- Phone: 843-876-0758
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Transcatheter Aortic Valve Replacement, Anesthesia, TAVR, Cardiothoracic, Cardiology