The Hypotension Prediction Index in Free Flap Transplant in Head and Neck Surgery.

Jakub Szrama

Status: Enrolling

Conditions: Postoperative Complications; Hypotension; Perioperative Complication; Head and Neck Cancer

Treatments: Device: Hypotension Prediction Index

Study type: Interventional

Funder types: Other

Identifiers

NCT05738603

560/22

Details and patient eligibility

About

The aim of the current study is to evaluate the effects of the Hypotension Prediction Index (HPI) on the degree of intraoperative hypotension in patients undergoing free flap surgery. The hypothesis is that implementation of the HPI algorithm will reduce the time-weighted average (TWA) intraoperative hypotension below a threshold of 65 mmHg (16), and to reveal the relationship between the episodes of hypotension and free flap viability and function.

Enrollment: 206 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients qualified to head and neck free flap surgery
• Written informed consent

Exclusion criteria

• Patients under 18 years
• Lack of health insurance
• Pregnancy
• Known history of congenital heart disease, severe aortic and/or mitral stenosis, heart failure and ejection fraction < 35 %
• Persistent atrial fibrillation and other arrhythmias impairing arterial pressure-based cardiac output (APCO) monitoring

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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206 participants in 2 patient groups

Standard Therapy Group

No Intervention group

Description:

The standard therapy group patients will have invasive blood pressure monitoring + standard medical therapy. The therapeutic decision regarding treatment of hypotension, the use of fluids and vasopressors will be determined by the anaesthesia team. The decisions will be based on the information from the standard invasive blood pressure monitoring.

Hypotension Prediction Index Group

Experimental group

Description:

The HPI-group will have the HPI based monitoring with the Acumen IQ sensor (Edwards Lifesciences) and the HPI algorithm connected also to the HemoSphere platform (Edwards Lifesciences). The hemodynamic management will be based on the HPI indications and the specific algorithm, which considers hypovolemia, impaired contractility and vasodilatation. An alert pops up on the monitor screen when the HPI values exceeds 85 and then the clinician needs to make therapeutic decision in order to avoid the hypotensive episode.

Treatment:

Device: Hypotension Prediction Index