CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 68 enrolled
Drug / intervention
Hypotension Prediction Indexdevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05354661
NCT05354661N/ACompleted

Non-Invasive Hemodynamic Monitoring and Incidence of Perioperative Hypotension in Gynaecologic Oncologic Surgery: Hypotension Prediction Index Working With ClearSight Versus Arterial Waveform Analysis Alone

Fondazione Policlinico Universitario Agostino Gemelli IRCCS·observational·Posted Apr 29, 2022·Updated May 31, 2022

In Brief

An observational study evaluating Hypotension Prediction Index for Hypotension and 2 related conditions. Completed, enrolled 68 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 29, 2022
Enrollment StartDec 1, 2019
Primary CompletionFeb 1, 2020
Study CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.2 years ago

Interventions

Hypotension Prediction Indexdevice

treatment of hypotension before the appearance following HPI algorithm