Intraoperative Implementation of the Hypotension Probability Indicator
- Conditions
- Intraoperative Hypotension
- Interventions
- Device: FlotracIQ with HPI algorithm
- Registration Number
- NCT03376347
- Brief Summary
Reducing intraoperative hypotension using FlotracIQ with HPI software.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Aged 18 years or older
- Planned for elective non-cardiac non-day surgery with an expected duration of more than 2 hours
- Planned to receive general anaesthesia
- Planned to receive an arterial line during surgery
- Aim for MAP of 65 mmHg during surgery
- Being able to give written informed consent prior to surgery
- Aim for MAP other than 65 mmHg at discretion treating physician
- Significant hypotension before surgery defined as a MAP <65
- Right- or left sided cardiac failure (e.g. LVEF<35%)
- Known cardiac shunts (significant)
- Known aortic stenosis (severe)
- Severe cardiac arrhythmias including atrial fibrillation
- Requiring dialysis
- Liver surgery
- Vascular surgery with clamping of the aorta
- Perioperative Goal Directed Therapy (PGDT) protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment arm FlotracIQ with HPI algorithm FlotracIQ with HPI algorithm.
- Primary Outcome Measures
Name Time Method TWA hypotension (measured with FlotracIQ) intraoperative, starting 15 minutes after induction Time weighted average spent in hypotension, defined as MAP \<65mmHg for ≥1min
- Secondary Outcome Measures
Name Time Method TWA hypertension (measured with FlotracIQ) intraoperative, starting 15 minutes after induction Time weighted average spent in hypertension, defined as MAP \>100 mmHg for ≥1min
Incidence of hypotension (measured with FlotracIQ) intraoperative, starting 15 minutes after induction Incidence of hypotension, defined as MAP \<65mmHg for ≥1min
Treatment choice (CRF, EPD) intraoperative, starting 15 minutes after induction Medication used to prevent/treat hypotension. A study member is present at the OR to make notes
Time to treatment (CRF) intraoperative, starting 15 minutes after induction time to treatment of hypotension, defined as MAP \<65mmHg for ≥1min. A study member is present at the OR to make notes
Time spent in hypotension (measured with FlotracIQ) intraoperative, starting 15 minutes after induction Time spent in hypotension, in minutes, defined as MAP \<65mmHg for ≥1min
Incidence of hypertension (measured with FlotracIQ) intraoperative, starting 15 minutes after induction Incidence of hypertension, defined as MAP \>100 mmHg for ≥1min.
Percentage of time in hypertension (measured with FlotracIQ) intraoperative, starting 15 minutes after induction Percentage of time in hypertension, defined as MAP \>100 mmHg for ≥1min
Diagnostic guidance protocol deviations (CRF) intraoperative, starting 15 minutes after induction Diagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.
Treatment dose (CRF, EPD) intraoperative, starting 15 minutes after induction Dose of medication used to prevent/treat hypotension. A study member is present at the OR to make notes
Trial Locations
- Locations (1)
Academic Medical Center Amsterdam
🇳🇱Amsterdam, Netherlands