CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
Hypotension Predictive Indexdevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06097052
NCT06097052N/ACompleted

The Effect of Hypotension Predictive Index on Intraoperative Hypotension Events and Duration During Pancreatic Surgery. A Retrospective Pre-post Observational Study.

Istituto Clinico Humanitas·observational·Posted Oct 24, 2023·Updated Mar 6, 2024

In Brief

An observational study evaluating Hypotension Predictive Index for Hypotension During Surgery and Perioperative Complication. Completed, enrolled 48 participants across 1 site.

Detailed Summary

Intraoperative hypotension (IOH) is a sudden clinical phenomenon that occurs frequently during general anesthesia. Prevention of IOH has been linked to reduced postoperative organ damage and decreased incidence of perioperative complications. Oncological patients with reduced preoperative physiological reserves may be especially vulnerable to IOH deleterious effects, especially when exposed to prolonged surgical time increase, as it is the case for patients undergoing pancreatic surgery. The investigators aim to study introduction of a new technology able to predict hypotensive events (Hypotension Predictive Index, HPI Acumen™) in terms of its effects on IOH occurrence and burden in patients undergoing pancreatic surgery. The investigators will enroll patients before and after the introduction of HPI monitoring. Further, differences in postoperative outcomes and perioperative complications between before and after populations will be investigated.

Study Details

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

Timeline

N/ACompletedFinished
202420252026
First PostedOct 24, 2023
Enrollment StartMay 23, 2023
Primary CompletionDec 1, 2023
Study CompletionJan 31, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.7 years ago

Interventions

Hypotension Predictive Indexdevice

Introduction of Hypotension Predictive index and transition from a reactive to a proactive approach of intraoperative hypotension treatment.