CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 153 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04643834
NCT04643834N/ACompleted

Validation of Cerebral Non-invasive Monitoring and Prediction of Post-operative Delirium and Outcomes: A Prospective Observational Study

Montreal Heart Institute·observational·Posted Nov 25, 2020·Updated Mar 19, 2024

In Brief

An observational study for Delirium and 2 related conditions. Completed, enrolled 153 participants across 1 site.

Detailed Summary

Brain monitoring using near-infrared spectroscopy (NIRS) started in 2002 in the operating room of the Montreal heart Institute (MHI). This was followed by the use of somatic NIRS in 2010, transcranial Doppler in 2015 and processed electroencephalogram (pEEG) using Sedline (Masimo, Irvine CA) in 2017. The introduction of those modalities led to significant change in intraoperative management. The goal of these devices is to improve our ability to detect and predict post-operative complications as well as offering insights on how to prevent them. The current project explores in further detail the impact of the introduction of pEEG in the operating room and in the intensive care unit (ICU) on post-operative delirium.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada
CollaboratorsMasimo Corporation

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 25, 2020
Enrollment StartNov 21, 2019
Primary CompletionSep 30, 2023
Study CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 5.6 years ago