NCT06133842 CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State
| NCT ID | NCT06133842 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Perioperative/Postoperative Complications |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-04-17 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-04-17 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 60 years * Undergoing any non-cardiac surgeries including but not limited to vascular, hepatobiliary, or complex spine surgeries requiring general anesthesia with arterial catheterization for monitoring Exclusion Criteria: 1. Non-English speaking (Justification: cognitive assessment instruments are not validated in a sufficient range of languages, and the research team lacks polylingual capabilities or the financial resources to hire interpreters for the duration of all proposed assessments.) 2. Cognitive impairment as defined by total MoCA score \< 10 (justification: baseline cognitive dysfunction will confound primary outcome measure) 3. Significant visual impairment (justification: will be difficult for patients to draw individual components in MOCA score) 4. Emergent surgery (justification: insufficient time to initiate intervention) 5. History of stroke within the last 3 months (justification: cognitive dysfunction secondary to stroke can confound outcome measures
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06133842 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Perioperative/Postoperative Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06133842 currently recruiting?
Yes, NCT06133842 is actively recruiting participants. Contact the research team at skendale@bidmc.harvard.edu for enrollment information.
Where is the NCT06133842 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06133842 clinical trial?
NCT06133842 is sponsored by Beth Israel Deaconess Medical Center. The trial plans to enroll 100 participants.