Key result
This is a study protocol for a randomized controlled trial evaluating the impact of the Hypotension Prediction Index on intraoperative hypotension; no results are reported.
Why the study?
Intraoperative hypotension during head and neck free flap surgery increases mortality, morbidity, and flap failure, prompting evaluation of the Hypotension Prediction Index to reduce its incidence and severity.
Does hemodynamic monitoring using the Hypotension Prediction Index (HPI) software reduce intraoperative hypotension in patients undergoing free flap surgery for head and neck cancer?
RCT
Randomly assigned
Does hemodynamic monitoring using the Hypotension Prediction Index (HPI) software reduce intraoperative hypotension in patients undergoing free flap surgery for head and neck cancer?
RCT protocol for Hypotension Prediction Index published; leaves open its impact on intraoperative hypotension until results emerge.
INTRODUCTION: Microvascular free flap surgery is a treatment method for patients with head and neck cancer requiring reconstruction surgery. Patients undergoing this complex, long-lasting surgery are prone to prolonged episodes of intraoperative hypotension, which is associated with increased incidence of postoperative mortality, morbidity, and free flap failure. A new technology recently approved, named the Hypotension Prediction Index (HPI), allows precise hemodynamic monitoring of patients under general anesthesia, with a significant reduction of intraoperative hypotension events. This study aims to assess the impact of the Hypotension Prediction Index (HPI) on the incidence and severity of intraoperative hypotension in patients undergoing free flap surgery. METHODS AND ANALYSIS: Eligible patients will be randomly assigned to one of two groups: Group A, receiving invasive blood pressure monitoring with standard medical therapy, or Group B, undergoing hemodynamic monitoring using the Hypotension Prediction Index (HPI) software. The primary outcome is the time-weighted average (TWA) of mean arterial pressure (MAP) < 65 mmHg. Secondary outcomes include free flap viability and perioperative complications. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Poznan University of Medical Sciences Ethics Committee (KB-560/22; date 1 July 2022). Results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05738603.
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Szrama et al. (2025) conducted an RCT in Head and neck cancer requiring reconstruction surgery. Hypotension Prediction Index (HPI) software vs. Invasive blood pressure monitoring with standard medical therapy was evaluated on Time-weighted average (TWA) of mean arterial pressure (MAP) < 65 mmHg. This is a study protocol for a randomized controlled trial evaluating the impact of the Hypotension Prediction Index on intraoperative hypotension; no results are reported.
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