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NCT06133842 · ClinicalTrials.gov registry record
CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State
A clinical trial of Postoperative Delirium and Perioperative/Postoperative Complications, sponsored by Beth Israel Deaconess Medical Center.
- Recruiting
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT06133842: Recruiting study of Postoperative Delirium and Perioperative/Postoperative Complications, sponsored by Beth Israel Deaconess Medical Center.
NCT06133842 is a study of Postoperative Delirium and Perioperative/Postoperative Complications that is actively recruiting participants, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 100 participants, below the 170-participant average among 8 other Postoperative Delirium trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06133842, a study of Postoperative Delirium and Perioperative/Postoperative Complications, is actively recruiting participants, sponsored by Beth Israel Deaconess Medical Center.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this observational study is to learn the how to determine the mean arterial pressure(MAP) or blood pressure level to be maintained during non-cardiac surgery for optimal brain health in patients above the age of 60 undergoing major non-cardiac surgery. The main question\[s\] it aims to answer are: * Is there a way to tailor the blood pressure to be maintained in such patients during surgery for optimal brain health using non-invasive monitors that check the brains electrical activity, the electroencephalogram(EEG) monitor, and the brain's blood oxygen levels, the cerebral oximetry(CO) monitor? * How much does this optimal blood pressure level vary between patients? Participants will be asked to: * Complete a questionnaire at the time they enroll into the study, as well as a daily questionnaire to help determine their level of thinking and brain health. This questionnaire will be administered by a member of the study team. * They will also have an EEG and CO monitoring sticker placed on their foreheads. This will be connected to a monitor that will collect this data just before, during, and after their surgery. The data collected through these monitors will help us with our study goals.
Primary Outcome
The primary outcome will be reliability in the form of an "uptime". This is a calculation of the percentage that each signal provides a feasible measurement, and a percentage that each method of autoregulation calculation produces an output. Previous studies have demonstrated a high frequency of uptime, upwards of 90%. CA state and lower limits of autoregulation (LLA) will be calculated using two distinct methods, both previously published and enumerated in the Statistical Consideration section
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Intra-op EEG and CO data collection
Study Locations (1)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-04-17 |
| Est. Completion | 2027-07 |
What NCT06133842 shows while recruiting
NCT06133842 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 170-participant average among 8 other Postoperative Delirium trials with a reported enrollment target (41% lower).
The record links to 6 conditions, with Postoperative Delirium appearing as the primary indexed condition, and to 1 intervention - of which Intra-op EEG and CO data collection is the first listed.
NCT06133842 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06133842 about?
NCT06133842 is a clinical study titled "CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State". The goal of this observational study is to learn the how to determine the mean arterial pressure(MAP) or blood pressure level to be maintained during non-cardiac surgery for optimal brain health in patients above the age of 60 undergoing major non-cardiac surgery. The main question\[s\] it aims to a...
What is the current status of trial NCT06133842?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2024-04-17. Estimated completion is 2027-07.
What conditions does trial NCT06133842 study?
This clinical trial studies the following conditions: Postoperative Delirium, Perioperative/Postoperative Complications, Postoperative Cognitive Dysfunction, Intraoperative Hypotension, EEG With Periodic Abnormalities.
What interventions are being tested in trial NCT06133842?
The interventions under investigation include: Intra-op EEG and CO data collection (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06133842?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06133842 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06133842's enrollment target sits among peer trials
100 5th of 8 higher than 3 of 8 other Postoperative Delirium trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Delirium trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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