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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol-dominant Sedation | Patients receiving propofol infusion for TAVR as the primary drug for sedation. |
| |
| Dexmedetomidine-dominant Sedation | Patients receiving dexmedetomidine infusion for TAVR as the primary drug for sedation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine with propofol | Drug | A dexmedetomidine- dominant anesthetic will be defined as an anesthetic that included a continuous infusion of dexmedetomidine within 15 minutes of anesthesia start. This group was subsequently modified in light of retrospective data collection to specify a group receiving dexmedetomidine in combination with propofol. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Length | Procedure length will be collected from retrospective analysis of charts. | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Length of Stay | ICU length of stay will be collected from retrospective analysis of charts. | From the conclusion of surgery until patient leaves the ICU, up to 2 weeks |
| Rate of Conversion to General Anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent TAVR under a plan for conscious sedation with monitored anesthetic care rather than general anesthesia.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Schonberger, MD | Yale University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24612945 | Background | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Statistical Analysis Plan | View IPD |
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As specified above, this study was a retrospective chart review and thus enrollment was determined by existence of charts rather than by prospective enrollment. While patients were screened for other modes of sedation, data were only collected on the two groups included presently.
This study was a retrospective chart review and did not include prospective enrollment. As noted in the pre-assignment details, the number of enrolled participants was determined by chart review.
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol-dominant Sedation | Patients receiving propofol infusion for TAVR as the primary drug for sedation. Propofol: A propofol-dominant anesthetic will be defined as an anesthetic that included a continuous infusion of propofol within 15 minutes of anesthesia start. |
| FG001 | Propofol With Dexmedetomidine Group | Patients who qualified for Both the Propofol Dominant and the Dexmedetomidine Dominant group were categorized into this fourth group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This study was not a clinical trial but rather a retrospective observational study in which arms were developed based on an understanding of the descriptive data. As stated in the manuscript, "As the dexmedetomidine-dominant and fentanyl-dominant groups had limited sample size, the authors decided to focus on the propofol-dominant and dexmedetomidine plus propofol groups for analysis of outcomes."
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol and Dexmedetomidine | Defined as any MAC that included both propofol and dexmedetomidine and may have included fentanyl, remifentanil, or midazolam |
| BG001 | Propofol Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Procedure Length | Procedure length will be collected from retrospective analysis of charts. | NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort. | Posted | Median | Inter-Quartile Range | minutes | During surgery |
|
Retrospective study. No adverse events.
Retrospective study. No adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propofol and Dexmedetomidine | Defined as any MAC that included both propofol and dexmedetomidine and may have included fentanyl, remifentanil, or midazolam. NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Schonberger | Yale School of Medicine | 2037852802 | robert.schonberger@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 19, 2016 | Apr 2, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 13, 2021 | Aug 13, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Propofol | Drug | A propofol-dominant anesthetic will be defined as an anesthetic that included a continuous infusion of propofol within 15 minutes of anesthesia start. This definition was subsequently modified to include patients who received propofol infusion but not dexmedetomidine. |
|
|
Rate of conversion to general anesthesia will be collected from retrospective analysis of charts.
| During surgery |
| Hospital Length of Stay | Hospital length of stay will be collected via retrospective analysis of charts. | From the conclusion of surgery until patient is discharged, up to 2 weeks |
| Delirium Incidence | Whether or not the patient experiences delirium during their hospital stay as recorded in their notes by the treating physician. | From the conclusion of surgery until patient is discharged, up to 2 weeks |
Defined as any MAC that included propofol infusions or injections in the absence of dexmedetomidine. These patients also may have received injections of fentanyl, remifentanil, or midazolam.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height | Median | Inter-Quartile Range | meters |
|
| Weight | Median | Inter-Quartile Range | kg |
|
| Body Mass Index (BMI) | Median | Inter-Quartile Range | kg/m^2 |
|
| American Society of Anesthesiologists (ASA) Physical Status Score | ASA Physical Status is a measure of comorbidity developed by the American Society of Anesthesiologists. It is graded ordinally from 1 to 6 whereby 1 represents a healthy patient, 4 a patient with serious systemic disease, 5 a moribund patient, and 6 a brain dead individual presenting for organ donation after death. | Count of Participants | Participants |
|
| New York Heart Association Congestive Heart Failure (NYHA CHF)HF classification | NYHA CHF is graded from 1 to 4 in which 1 is a person without heart failure, 2 is a person with sympoms only during exercise, and 3 iand 4 are progressively more serious stages of heart failure. | Count of Participants | Participants |
|
| Left ventricular ejection fraction (LVEF) | Median | Inter-Quartile Range | % |
|
| Alcoholism | Count of Participants | Participants |
|
| Anxiety disorder | Count of Participants | Participants |
|
| Atrial fibrillation | Count of Participants | Participants |
|
| Cerebrovascular disease | Count of Participants | Participants |
|
| Congestive Heart Failure (CHF) | Count of Participants | Participants |
|
| Coronary Artery Disease (CAD) | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Depression | Count of Participants | Participants |
|
| Obstructive sleep apnea | Count of Participants | Participants |
|
| Peripheral vascular disease | Count of Participants | Participants |
|
| Psychosis | Count of Participants | Participants |
|
| Renal disease | Count of Participants | Participants |
|
| Substance abuse | Count of Participants | Participants |
|
|
|
| Secondary | ICU Length of Stay | ICU length of stay will be collected from retrospective analysis of charts. | NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort. | Posted | Median | Inter-Quartile Range | days | From the conclusion of surgery until patient leaves the ICU, up to 2 weeks |
|
|
|
| Secondary | Rate of Conversion to General Anesthesia | Rate of conversion to general anesthesia will be collected from retrospective analysis of charts. | NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort. | Posted | Count of Participants | Participants | During surgery |
|
|
|
| Secondary | Hospital Length of Stay | Hospital length of stay will be collected via retrospective analysis of charts. | NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort. | Posted | Median | Inter-Quartile Range | days | From the conclusion of surgery until patient is discharged, up to 2 weeks |
|
|
|
| Secondary | Delirium Incidence | Whether or not the patient experiences delirium during their hospital stay as recorded in their notes by the treating physician. | NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort. | Posted | Count of Participants | Participants | From the conclusion of surgery until patient is discharged, up to 2 weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Propofol Only | Defined as any MAC that included propofol infusions or injections in the absence of dexmedetomidine. These patients also may have received injections of fentanyl, remifentanil, or midazolam. NB: The analyzed groups are the subset of the participant arms that were deemed to have sufficient numbers for comparison. Other groups were excluded from analysis after descriptive understanding of the makeup of this retrospective cohort. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014694 |
| Ventricular Outflow Obstruction |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |