Reducing intraoperative hypotension using FlotracIQ with HPI software.
Intraoperative hypotension occurs often. Even short durations of hypotension are suggested to be associated with increased risk for renal insufficiency and myocardial ischemia. Currently treatment of these hypotensive episodes is not proactive. Edwards Lifesciences has developed an algorithm using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases. Hypothesis: the use of this algorithm will alter treatment of hypotension and reduces the incidence of hypotension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
FlotracIQ with hypotension probability indicator (HPI) algorithm connected to arterial line. The treating anesthetist is provided with guidance by means of a flowchart suggesting when to treat and what. Timing of treatment and choice of treatment is then left to the discretion of the attending physician.
Academic Medical Center Amsterdam
Amsterdam, Netherlands
TWA hypotension (measured with FlotracIQ)
Time weighted average spent in hypotension, defined as MAP \<65mmHg for ≥1min
Time frame: intraoperative, starting 15 minutes after induction
Incidence of hypotension (measured with FlotracIQ)
Incidence of hypotension, defined as MAP \<65mmHg for ≥1min
Time frame: intraoperative, starting 15 minutes after induction
Time spent in hypotension (measured with FlotracIQ)
Time spent in hypotension, in minutes, defined as MAP \<65mmHg for ≥1min
Time frame: intraoperative, starting 15 minutes after induction
TWA hypertension (measured with FlotracIQ)
Time weighted average spent in hypertension, defined as MAP \>100 mmHg for ≥1min
Time frame: intraoperative, starting 15 minutes after induction
Percentage of time in hypertension (measured with FlotracIQ)
Percentage of time in hypertension, defined as MAP \>100 mmHg for ≥1min
Time frame: intraoperative, starting 15 minutes after induction
Incidence of hypertension (measured with FlotracIQ)
Incidence of hypertension, defined as MAP \>100 mmHg for ≥1min.
Time frame: intraoperative, starting 15 minutes after induction
Treatment choice (CRF, EPD)
Medication used to prevent/treat hypotension. A study member is present at the OR to make notes
Time frame: intraoperative, starting 15 minutes after induction
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Treatment dose (CRF, EPD)
Dose of medication used to prevent/treat hypotension. A study member is present at the OR to make notes
Time frame: intraoperative, starting 15 minutes after induction
Time to treatment (CRF)
time to treatment of hypotension, defined as MAP \<65mmHg for ≥1min. A study member is present at the OR to make notes
Time frame: intraoperative, starting 15 minutes after induction
Diagnostic guidance protocol deviations (CRF)
Diagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.
Time frame: intraoperative, starting 15 minutes after induction