Death, Myocardial Infarction, Postoperative Complications, Renal Failure, Stroke
Conditions
Keywords
blood pressure, mean arterial pressure, MAP, intraoperative, postoperative, anesthesia
Brief summary
The purpose of this study is to determine 1. whether intraoperative hypotension or hypertension is independently associated with postoperative mortality and morbidity 2. whether quality improvement interventions implemented at the University of Michigan and at Washington University: 1. decrease the extent and duration of intraoperative hypotension and hypertension. 2. are associated with decreased postoperative mortality and morbidity.
Detailed description
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 A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials.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.
Interventions
OTHERFACE quality improvement initiative (see below)
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.
OTHERPre-quality improvement initiative
Patients in the pre-quality improvement initiative arm would receive current standard practice.
Sponsors
University of Michigan
Washington University School of Medicine
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan between 8/1/2009 and 10/31/2012
Exclusion criteria
* Patients undergoing organ harvest or terminal surgical procedure (American Society of Anesthesiologists physical status 6) * Patients without a Social Security Number
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of postoperative all cause mortality | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of postoperative all cause mortality | 1 year | — |
| incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure) | 1 year | — |
| incidence of morbidity and mortality for predefined subgroups | 1 year | 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 |
| episode, duration, and extent of intraoperative hypotension and hypertension | intraoperative | — |
| Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality | 1 year | — |
Countries
United States
Outcome results
None listed