Intraoperative Implementation of the Hypotension Probability Indicator

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-08

Study Completion Date

2019-03-20

Brief Summary

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Reducing intraoperative hypotension using FlotracIQ with HPI software.

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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.

Conditions

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Intraoperative Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional arm

Institutional Standard of Care with intention to keep MAP\> 65 mmHg. The FlotracIQ will be connected, but fully covered.

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment arm

FlotracIQ with HPI algorithm.

Group Type ACTIVE_COMPARATOR

FlotracIQ with HPI algorithm

Intervention Type 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.

Interventions

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FlotracIQ 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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes