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unable to implement the intervention
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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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The purpose of this study is to determine
whether intraoperative hypotension or hypertension is independently associated with postoperative mortality and morbidity
whether quality improvement interventions implemented at the University of Michigan and at Washington University:
Recent epidemiological data from an European study suggests that the 30-day postoperative mortality rate reaches a rate of about 1 in 50. A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials. Many factors are associated strongly and independently with postoperative morbidity and mortality; including patient age, functional status, comorbid medical conditions, and duration and invasiveness of the surgery. It is imperative to identify modifiable factors for possible intervention.
With the advent of electronic intraoperative medical record, intraoperative hemodynamic factors can be assessed as a potential contributor to postoperative morbidity and mortality. Recent studies have shown that intraoperative hypotension occurs commonly and is associated with both early and late postoperative mortality. The investigators goal is to conduct a study that might help to clarify whether intraoperative blood pressure management might be interdependently associated with postoperative morbidity and mortality. There are two phases in this trial: pre-quality improvement phase and post quality improvement phase. Pre-quality improvement phase data will be used as a baseline control group. Data from this phase will also be used to establish whether there appears to be an independent association between intraoperative blood pressure management and postoperative morbidity and mortality. The Anesthesiology Departments at Washington University in St. Louis and at the University of Michigan are implementing quality improvement initiatives in relation to intraoperative blood pressure management. Following implementation of the quality improvement initiatives, the investigators plan to determine whether: a) there is an improvement in intraoperative blood pressure management; b) whether there is a decrease in postoperative morbidity and mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-quality improvement cohort | Patient cohort after FACE quality improvement initiative is implemented |
| |
| Pre-quality improvement cohort | Patient cohort prior to implementation of FACE quality improvement initiative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FACE quality improvement initiative (see below) | Other | Feedback (F): Regular feedback to practitioners; MAP Alerts (A): Change in electronic alert systems for high and low mean arterial pressure with patient specific alerts; Checklist (C): Interactive checklist in relation to the quality improvement initiative; Education campaign (E): Education campaigns about best intraoperative management of blood pressure. |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative all cause mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative all cause mortality | 1 year | |
| incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure) | 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
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All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Avidan, MBBCh | Washington University School of Medicine | Principal Investigator |
| Sachin Kheterpal, MD | University of Michigan | Principal Investigator |
| Alex S Evers, MD | Washington University School of Medicine | Study Chair |
| Kevin Tremper, MD PhD | University of Michigan | Study Chair |
| Anshuman Sharma, MD | Washington University School of Medicine | Study Director |
| Dan Helsten, MD | Washington University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Medicine | Ann Arbor | Michigan | 48109 | United States | ||
| Washington University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20418691 | Background | Noordzij PG, Poldermans D, Schouten O, Bax JJ, Schreiner FA, Boersma E. Postoperative mortality in The Netherlands: a population-based analysis of surgery-specific risk in adults. Anesthesiology. 2010 May;112(5):1105-15. doi: 10.1097/ALN.0b013e3181d5f95c. | |
| 20418692 | Background | Kertai MD, Pal N, Palanca BJ, Lin N, Searleman SA, Zhang L, Burnside BA, Finkel KJ, Avidan MS; B-Unaware Study Group. Association of perioperative risk factors and cumulative duration of low bispectral index with intermediate-term mortality after cardiac surgery in the B-Unaware Trial. Anesthesiology. 2010 May;112(5):1116-27. doi: 10.1097/ALN.0b013e3181d5e0a3. |
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|
| Pre-quality improvement initiative | Other | Patients in the pre-quality improvement initiative arm would receive current standard practice. |
|
| incidence of morbidity and mortality for predefined subgroups |
patients with pre-existing hypertension, specific organ system diseases (coronary artery disease, cerebrovascular disease, peripheral vascular disease, renal dysfunction), elderly (>65 yrs of age), American Society of Anesthesiologist physical status 3,4,5, and patients receiving emergency surgery |
| 1 year |
| episode, duration, and extent of intraoperative hypotension and hypertension | intraoperative |
| Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality | 1 year |
| St Louis |
| Missouri |
| 63110 |
| United States |
| 15616043 | Background | Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E. |
| 19934864 | Background | Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930. |
| 19212261 | Background | Kheterpal S, Tremper KK, Heung M, Rosenberg AL, Englesbe M, Shanks AM, Campbell DA Jr. Development and validation of an acute kidney injury risk index for patients undergoing general surgery: results from a national data set. Anesthesiology. 2009 Mar;110(3):505-15. doi: 10.1097/ALN.0b013e3181979440. |
| 20571360 | Background | Aronson S, Stafford-Smith M, Phillips-Bute B, Shaw A, Gaca J, Newman M; Cardiothoracic Anesthesiology Research Endeavors. Intraoperative systolic blood pressure variability predicts 30-day mortality in aortocoronary bypass surgery patients. Anesthesiology. 2010 Aug;113(2):305-12. doi: 10.1097/ALN.0b013e3181e07ee9. |
| ID | Term |
|---|---|
| D003643 | Death |
| D011183 | Postoperative Complications |
| D009203 | Myocardial Infarction |
| D020521 | Stroke |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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