Intraoperative Hypotension
Conditions
Keywords
intraoperative, hypotension, Hypotension Probability Index, HPI
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.
Interventions
DEVICEFlotracIQ with HPI algorithm
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.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TWA hypotension (measured with FlotracIQ) | intraoperative, starting 15 minutes after induction | Time weighted average spent in hypotension, defined as MAP \<65mmHg for ≥1min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| TWA hypertension (measured with FlotracIQ) | intraoperative, starting 15 minutes after induction | Time weighted average spent in 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 |
| Incidence of hypertension (measured with FlotracIQ) | intraoperative, starting 15 minutes after induction | Incidence of 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 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 |
| 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 |
| 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 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 |
Countries
Netherlands
Outcome results
None listed