Clinical trial NCT02786264: Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
Official title: Pilot Analysis of the Association Between Types of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: transcatheter aortic valve replacement
anesthesia
conscious sedation
managed anesthesia care
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 186
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent TAVR under a plan for conscious sedation with monitored anesthetic care rather than general anesthesia.

Brief summary: This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive transfemoral aortic valve replacements (TAVR) at Yale New Haven Hospital (YNHH).

Detailed description: This study proposes to perform a descriptive analysis and pilot observational study looking at the types and quantity of anesthetic agents used and their associations with outcomes among patients scheduled to receive TAVR at YNHH.

Hypothesis 1: TAVR surgery done under monitored anesthesia care are performed using some combination of the following anesthetics: dexmedetomidine, propofol, fentanyl, and midazolam.

Hypothesis 2: Age-adjusted dosing of these agents will be insufficient to account for extreme age after controlling for preoperative comorbid status.

Hypothesis 3: The rate of conversion to general anesthesia will be unrelated to the type of conscious sedation used.

Hypothesis 4: ICU length of stay, delirium, hospital length of stay, and length of hospital stay will be shorter for patients who were sedated using dexmedetomidine vs those without.

Research Plan: The research will be done via chart review and analysis of data already contained in the Multicenter Perioperative Outcomes Group databases at Yale. The possible risks are primarily the risk to privacy that is inherent in any retrospective chart review. The benefit may be to suggest areas of future study to improve sedation practices for TAVR at Yale and elsewhere. Information recorded will include demographic and preoperative medical assessment from prior to the TAVR, the anesthetic record, and the post-operative course of recovery for patients undergoing TAVR. These data will include age, gender, comorbidities, laboratory values, vital signs, and the results of imaging studies as well as other records potentially related to the above hospitalization.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent TAVR at YNHH under planned conscious sedation with monitored anesthetic care

Exclusion Criteria:

* Patients who received monitored anesthesia care without the receipt of any study intervention drug (propofol, fentanyl, midazolam, or dexmedetomidine).

Primary outcomes:
measure: Procedure Length
timeFrame: During surgery
Secondary outcomes:
measure: ICU Length of Stay
timeFrame: From the conclusion of surgery until patient leaves the ICU, up to 2 weeks
measure: Rate of Conversion to General Anesthesia
timeFrame: During surgery
measure: Hospital Length of Stay
timeFrame: From the conclusion of surgery until patient is discharged, up to 2 weeks
measure: Delirium Incidence
timeFrame: From the conclusion of surgery until patient is discharged, up to 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Robert Schonberger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frohlich GM, Lansky AJ, Webb J, Roffi M, Toggweiler S, Reinthaler M, Wang D, Hutchinson N, Wendler O, Hildick-Smith D, Meier P. Local versus general anesthesia for transcatheter aortic valve implantation (TAVR)--systematic review and meta-analysis. BMC Med. 2014 Mar 10;12:41. doi: 10.1186/1741-7015-12-41.