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

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

RECRUITING

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypotension Head and Neck Cancer Perioperative Complication Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This prospective, randomized, controlled clinical trial will be performed in Poznan University of Medical Science Hospital. Patients fulfilling the inclusion criteria (see below) will be randomly assigned to receive invasive blood pressure monitoring + standard medical therapy (group A) or the hemodynamic monitoring with the Hypotension Prediction Index software (group B).

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

The studied patients will be blinded to the enrolled group.

Study Groups

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Standard Therapy Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Hypotension Prediction Index Group

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.

Group Type EXPERIMENTAL

Hypotension Prediction Index

Intervention Type DEVICE

Hemodynamic perioperative monitoring with the Hypotension Prediction Index

Interventions

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Hypotension Prediction Index

Hemodynamic perioperative monitoring with the Hypotension Prediction Index

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No