Intraoperative Implementation of the Hypotension Probability Indicator

Study Overview
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Brief Summary
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Reducing intraoperative hypotension using FlotracIQ with HPI software.

Detailed Description
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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.

Official Title
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HYPE Trial. Intraoperative Implementation of the Hypotension Probability Indicator (HPI) Algorithm: a Pilot Randomized Controlled Clinical Trial

Conditions
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Intraoperative Hypotension

Intervention / Treatment
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* Device: FlotracIQ with HPI algorithm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional arm<br>Institutional Standard of Care with intention to keep MAP> 65 mmHg. The FlotracIQ will be connected, but fully covered. | |
| Active Comparator: Treatment arm<br>FlotracIQ with HPI algorithm. | Device: FlotracIQ with HPI algorithm<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoperative, hypotension, Hypotension Probability Index, HPI