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Effect of machine learning-guided haemodynamic optimization on postoperative free flap perfusion in reconstructive maxillofacial surgery: A study protocol

Study protocol for a randomized controlled trial published in British journal of clinical pharmacology (2023)

Last Updated: June 18, 2026Reviewed by: ASH Editorial Board
Research article — evidence reviewArticle reference
Evidence: Trial protocol (no results yet)Clinical LiteraturePražetina et al. · British journal of clinical pharmacology, 2024

Abstract

AIMS: Intraoperative hypotension and liberal fluid haemodynamic therapy are associated with postoperative medical and surgical complications in maxillofacial free flap surgery. The novel haemodynamic parameter hypotension prediction index (HPI) has shown good performance in predicting hypotension by analysing arterial pressure waveform in various types of surgery. HPI-based haemodynamic protocols were able to reduce the duration and depth of hypotension. We will try to determine whether haemodynamic therapy based on HPI can improve postoperative flap perfusion and tissue oxygenation by improving intraoperative mean arterial pressure and reducing fluid infusion. METHODS: We present here a study protocol for a single centre, randomized, controlled trial (n = 42) in maxillofacial patients undergoing free flap surgery. Patients will be randomized into an intervention or a control group. In the intervention, group haemodynamic optimization will be guided by machine learning algorithm and functional haemodynamic parameters presented by the HemoSphere platform (Edwards Lifesciences, Irvine, CA, USA), most importantly, HPI. Tissue oxygen saturation of the free flap will be monitored noninvasively by near-infrared spectroscopy during the first 24 h postoperatively. The primary outcome will be the average value of tissue oxygen saturation in the first 24 h postoperatively.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

Publication typeClinical Trial ProtocolJournal Article
Indexed MeSH termsHumansFree Tissue FlapsHypotensionHemodynamicsPerfusionMachine LearningRandomized Controlled Trials as Topic

Summary

This is a protocol for a single-centre randomized controlled trial (n = 42) testing whether haemodynamic optimization guided by the hypotension prediction index improves postoperative free-flap tissue oxygen saturation in maxillofacial surgery, measured over the first 24 hours.

Context

This article presents a study protocol for a single-center randomized controlled trial (n=42) assessing whether machine learning-guided haemodynamic optimization using the hypotension prediction index can improve postoperative free flap perfusion and tissue oxygenation in maxillofacial surgery. The trial will use the HemoSphere platform to guide intraoperative haemodynamic therapy, with tissue oxygen saturation monitored via near-infrared spectroscopy during the first 24 postoperative hours. The abstract contains no mention of leeches, hirudotherapy, venous congestion, or leech-derived therapies. The study evaluates artificial intelligence and functional haemodynamic monitoring technology.

Citation

Reference (Vancouver style)

Pražetina M, Šribar A, Sokolović Jurinjak I, Matošević J, Peršec J. Effect of machine learning-guided haemodynamic optimization on postoperative free flap perfusion in reconstructive maxillofacial surgery: A study protocol. Br J Clin Pharmacol. 2024;90(3):684-690. doi:10.1111/bcp.15942. PMID: 37876305

Bibliographic details (authors, volume, pages, DOI) are taken from the PubMed record.

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