Intraoperative Implementation of the Hypotension Probability Indicator (HYPE)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Completed

Conditions: Intraoperative Hypotension

Treatments: Device: FlotracIQ with HPI algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT03376347

NL 6211501817

Details and patient eligibility

About

Reducing intraoperative hypotension using FlotracIQ with HPI software.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Conventional arm

No Intervention group

Description:

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

Treatment arm

Active Comparator group

Description:

FlotracIQ with HPI algorithm.

Treatment:

Device: FlotracIQ with HPI algorithm