A Effectiveness Trial of Early Hemodynamic Support in Patients Demonstrating a Low Systolic Blood Pressure
Status: | Withdrawn |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/27/2018 |
Start Date: | July 2012 |
End Date: | December 2013 |
The investigators thus propose to use an innovative randomized effectiveness trial design to
test the theory that early automatic identification of a ¡ Low Systolic Blood Pressure¡±
clinical condition and decision-support alerts will prompt earlier hemodynamic support and a
consequently reduce the duration of such conditions. Specifically, the investigators will
test the hypothesis that providing DSS alerts in regards to hypotension reduces the duration
of hypotensive episodes. The core of the investigators study will be an existing electronic
anesthesia record and smart-alarm decision-support system. All patients undergoing surgery at
Hillcrest will be randomly assigned to routine care or to DSS support. In patients assigned
to DSS support, a systolic blood pressure less than 80 mmHg will generate a warning within
three minutes after detection. Clinicians will be free to act on the alert, ignore the alert,
or to consider the provided information without acting on it. The randomization, complete
anesthesia record, detailed record of hypotensive events, alerts provided, clinician
responses, and SAP response, will be captured by the investigators electronic record-keeping
system. The investigators primary outcome will be the duration of time the patient has a
systolic blood pressure less than 80 mmHg. Secondary outcome will be duration of
hospitalization. The investigators will assess the effect of the alert on the primary outcome
of time to SBP returning to above 80 mmHg using survival analysis, with time to event
censored (and considered a non-event) at either the end of surgery or end of monitoring if
patient did not return to above 80 mmHg.
test the theory that early automatic identification of a ¡ Low Systolic Blood Pressure¡±
clinical condition and decision-support alerts will prompt earlier hemodynamic support and a
consequently reduce the duration of such conditions. Specifically, the investigators will
test the hypothesis that providing DSS alerts in regards to hypotension reduces the duration
of hypotensive episodes. The core of the investigators study will be an existing electronic
anesthesia record and smart-alarm decision-support system. All patients undergoing surgery at
Hillcrest will be randomly assigned to routine care or to DSS support. In patients assigned
to DSS support, a systolic blood pressure less than 80 mmHg will generate a warning within
three minutes after detection. Clinicians will be free to act on the alert, ignore the alert,
or to consider the provided information without acting on it. The randomization, complete
anesthesia record, detailed record of hypotensive events, alerts provided, clinician
responses, and SAP response, will be captured by the investigators electronic record-keeping
system. The investigators primary outcome will be the duration of time the patient has a
systolic blood pressure less than 80 mmHg. Secondary outcome will be duration of
hospitalization. The investigators will assess the effect of the alert on the primary outcome
of time to SBP returning to above 80 mmHg using survival analysis, with time to event
censored (and considered a non-event) at either the end of surgery or end of monitoring if
patient did not return to above 80 mmHg.
Inclusion Criteria:
- Patients will be enrolled in the study if systolic blood pressure (SBP) is measured to
be below 80 mmHg for at least 3 minutes, either with the arterial line or cuff
(non-invasive blood pressure, NIBP).
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