Study:
n/a
Rationale:
n/a
Purpose:
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.
Study Status: Recruiting
Recruiting:
Andrea Kurz, M.D. 216-445-9924 ak@or.org
| Condition |
Intervention |
Phase |
|
Intraoperative Low Blood Pressure |
Other: low blood pressure alert
Other: standard of care |
N/A |
Verified by
The Cleveland Clinic
February, 2013
Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov identifier: NCT01654835
Study Type: Interventional
Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Hillcrest Hospital Cleveland Clinic
Cleveland, Ohio 44195
United States
n/a