MedTrace Logo

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

NCT05354661 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2022-05-31

No results posted yet for this study

Summary

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.

Conditions

  • Hypotension
  • Hemodynamic Instability
  • Gynecologic Cancer

Interventions

DEVICE

Hypotension Prediction Index

treatment of hypotension before the appearance following HPI algorithm

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-02-01
Completion
2022-04-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05354661 on ClinicalTrials.gov