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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional arm | No Intervention | Institutional Standard of Care with intention to keep MAP> 65 mmHg. The FlotracIQ will be connected, but fully covered. | |
| Treatment arm | Active Comparator | FlotracIQ with HPI algorithm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlotracIQ with HPI algorithm | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| TWA hypotension (measured with FlotracIQ) | Time weighted average spent in hypotension, defined as MAP <65mmHg for ≥1min | intraoperative, starting 15 minutes after induction |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypotension (measured with FlotracIQ) | Incidence of hypotension, defined as MAP <65mmHg for ≥1min | intraoperative, starting 15 minutes after induction |
| Time spent in hypotension (measured with FlotracIQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M.W. Hollmann, MD, PhD | Academic Medical Center (AMC), Amsterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center Amsterdam | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32065827 | Derived | Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592. | |
| 31601239 |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Time spent in hypotension, in minutes, defined as MAP <65mmHg for ≥1min
| intraoperative, starting 15 minutes after induction |
| TWA hypertension (measured with FlotracIQ) | Time weighted average spent in hypertension, defined as MAP >100 mmHg for ≥1min | 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 | intraoperative, starting 15 minutes after induction |
| Incidence of hypertension (measured with FlotracIQ) | Incidence of hypertension, defined as MAP >100 mmHg for ≥1min. | 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 | intraoperative, starting 15 minutes after induction |
| Treatment dose (CRF, EPD) | Dose of medication used to prevent/treat hypotension. A study member is present at the OR to make notes | 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 | 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. | intraoperative, starting 15 minutes after induction |
| Derived |
| Wijnberge M, Schenk J, Terwindt LE, Mulder MP, Hollmann MW, Vlaar AP, Veelo DP, Geerts BF. The use of a machine-learning algorithm that predicts hypotension during surgery in combination with personalized treatment guidance: study protocol for a randomized clinical trial. Trials. 2019 Oct 11;20(1):582. doi: 10.1186/s13063-019-3637-4. |