Perioperative Hypotension in Gynaecologic Oncologic Surgery: HPI-ClearSight Versus Arterial Waveform Analysis

NCT05354661 COMPLETED

Background Intraoperative hypotension is associated with increased morbidity and mortality. The Hypotension Prediction Index (HPI) is an advancement of the arterial waveform analysis to predict intraoperative hypotension minutes before episodes occur enabling preventive treatments. This study will test the hypothesis that a hemodynamic treatment protocol based on HPI working with non-invasive ClearSight system reduces intraoperative hypotension when compared to standard goal directed therapy (GDT) in patients undergoing gynaecologic oncologic surgery. Methods A retrospective analysis of 68 adult consecutive patients undergoing gynaecologic oncologic surgery with non-invasive arterial pressure monitoring using either index guidance (HPI) or classic ClearSight system waveform analysis depending on availability (ClearSight, n = 36; HPI, n = 32) will be conducted. A hemodynamic GDT protocol was applied in both groups. The primary endpoint will be the incidence and duration of hypotensive events defined as MAP \<65 mmHg evaluated by time-weighted average of hypotension.

Details

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Status	COMPLETED
Enrolment	68
Start date	Sun Dec 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Apr 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Hypotension
• Hemodynamic Instability
• Gynecologic Cancer

Interventions

• Hypotension Prediction Index

Countries

Italy