Electroencephalographic Biomarker to Predict the Development of Postoperative Delirium: a Protocol of an Observational Study in a Cohort of Patients From Five Centers

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Acute post-operatory cognitive dysfunction states are one of the most important complications in older patients that underwent surgery. Among them postoperative delirium (POD) is the the most studied. Patients who develop delirium have poorer long-term outcomes, such as longer length of hospital stay, institutionalization at discharge, and even higher mortality, and consequently, the human and economic costs significantly increase for the health system. Here the research team will use an observational cohort, investigator blinded in five-center with a primary endpoint to validate intraoperative EEG analysis as a reliable biomarker of postoperative delirium.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 100
Healthy Volunteers: t
View:

• Age ≥ 60 years old

• Scheduled for high-risk elective surgery

• Need for at least 3 days of hospital stay after surgery

• Surgery performed under general anesthesia

• Written informed consent for participation in the trial

Locations
Other Locations
Chile
Hospital Clinico Universidad de Chile
RECRUITING
Santiago
Instituto Nacional del Cancer
RECRUITING
Santiago
Contact Information
Primary
Jose I Egana, MD, PhD
jiegana@uchile.cl
+56 2 2978 8209
Backup
Antonello Penna, MD, PhD
apenna@uchile.cl
+56 2 2978 8209
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 264
Treatments
Patients at risk of developing POD
* Patients older than 60 years~* Scheduled for elective surgery of moderate or high risk (defined as that which requires a subsequent hospitalization of at least 3 days) under general anesthesia.~* Signed informed consent.
Related Therapeutic Areas
Sponsors
Leads: University of Chile
Collaborators: Instituto Nacional del Cancer, Chile, Clinica Santa Maria, Pontificia Universidad Catolica de Chile, Hospital Base San Jose Osorno

This content was sourced from clinicaltrials.gov