COMPLETED

Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, and procedural mortality for patients undergoing Transcatheter Aortic Valve Replacement (TAVR). Also, the investigators hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.

Official Title

A Randomized Controlled Trial Comparing Monitored Anesthesia Care Versus General Anesthesia With Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement

Quick Facts

Study Start:2019-11-22
Study Completion:2025-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04107038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients ≥ 18 years old
  2. * Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis
  3. * Adult patients who are medically eligible to receive both anesthetics (GA and MAC)
  1. * Inability to speak English
  2. * Body Mass Index (BMI) \> 37 kg/m2
  3. * History of difficult airway requiring fiberoptic intubation
  4. * Inability to lie flat
  5. * Women who are pregnant
  6. * Patients who have contraindications to either anesthetic, such as an allergy or history of malignant hyperthermia, will also be excluded from the study.
  7. * Inability or unwillingness of subject to give informed consent based on any reason
  8. * Patients with any of the following absolute contraindications to TEE:
  9. * Perforated Viscus
  10. * Esophageal Stricture
  11. * Esophageal Tumor
  12. * Esophageal Perforation
  13. * Esophageal Diverticulum
  14. * Active upper GI Bleed

Contacts and Locations

Principal Investigator

George Whitener, M.D.
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina - Department of Anesthesia

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • George Whitener, M.D., PRINCIPAL_INVESTIGATOR, Medical University of South Carolina - Department of Anesthesia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-22
Study Completion Date2025-08-15

Study Record Updates

Study Start Date2019-11-22
Study Completion Date2025-08-15

Terms related to this study

Keywords Provided by Researchers

  • Anesthesia, TAVR, Cardiothoracic, Cardiology

Additional Relevant MeSH Terms

  • Transcatheter Aortic Valve Replacement