Prediction and Prevention of Postoperative Mortality and Morbidity

NANot yet recruitingINTERVENTIONAL
Enrollment

1,200

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

September 1, 2026

Study Completion Date

September 1, 2026

Conditions
Alzheimer DiseaseAlzheimer Disease Related Dementias
Interventions
OTHER

Personalized CPC Prehabilitation

Patients for elective surgery randomized to the intervention group will be scheduled for a preoperative evaluation (3-6 weeks prior to the surgical date) and will receive standardized and personalized assessment and prehabilitation according to UPMC's established disease-specific algorithms.

BEHAVIORAL

Cognitive Training

Participants will be provided with access to the Lumosity (Lumos Labs) software for installation on a home device. They will be trained to navigate the touchscreen tablet and guided through an introductory series of brain exercise games focused on 5 main categories: memory, speed, attention, flexibility, and problem-solving. Patients will be asked to complete a cognitive exercise dosage of a minimum of 20 minutes a day for ≥5 days prior to their date of surgery. Research coordinators and volunteers from UPMC's Hospital Elder Life Program (HELP) will reach out to participants daily for a quick social check-in and to remind them to perform their training. Compliance data will be retrieved from the Lumosity app.

BEHAVIORAL

Meditation

A single guided meditation session with instructions will be provided using a smart device. The meditation session will last for at least 10 minutes daily starting at least 1-week prior to surgery. If the subject does not own a smart device, one will be provided or meditation will be completed in-person or over the phone.

BEHAVIORAL

Daily Exercise

Participants in the intervention group will meet with an occupational or physical therapist approximately 1-6 weeks before surgery who will discuss the potential benefits of exercise and give directions for an easy strength training exercise. Participants will then be provided with a video link for a guided exercise and encouraged to walk or perform a seated strength exercise for ≥ 5 minutes each day for at least 1 week before surgery and after surgery. Patient reported frequency, fitness app compliance and exercise duration with REDCap email or mobile link or over telephone will be collected before and after surgery. Patients will be cleared by an occupational or physical therapist to perform the upper-extremity exercises and will confirm the exercises are not contraindicated after surgery. An occupational or physical therapist will see subject again post-surgery to mitigate risk of injury.

BEHAVIORAL

Enhanced Social Support

"Research coordinators and volunteers from HELP will reach out to patients daily prior to their surgery to discuss concerns they may have, provide daily social touchpoints, and remind them to perform their cognitive exercises. In addition, the importance of social support will be discussed with family members and other caregivers and they will be encouraged to participate.~e. Proactive depression treatment: All patients will receive preoperative interventions to manage their depression under their CPC prehabilitation program."

OTHER

Proactive Bundle Interventions

Participants randomized to the proactive bundled intervention group (Group D) will receive a routine intraoperative SSEP and EEG monitoring as well as optimization of intraoperative physiology by maintaining normal blood pressure, oxygen levels, opioid sparing analgesia, avoiding deep anesthesia and benzodiazepines. For example, increasing mean arterial pressure can stabilize SSEP (Fig. 6). If persistent focal changes in SSEP and EEG, (i.e., changes in one hemisphere) occur efforts will be made to increase brain perfusion by ensuring and maintaining hematocrit \>30, MAP \>70, and anesthetic BIS \>50-60; soon after surgery, patients will get stroke management and thrombectomy if indicated.

PROCEDURE

Pre-operative Standard of Care

Patients in the control group will receive standard of care pre-operative treatment, which may or may not include a visit to the CPC.

PROCEDURE

Intra-operative Standard of Care

This includes routine intraoperative SSEP and EEG monitoring. Physician oversight and interpretation of real-time neuromonitoring data will be performed using a combined on-site and remote model at UPMC. In the event that changes in EEG or SSEP are considered significant by the oversight neurophysiologists, the surgical team will be immediately informed so that immediate appropriate action can be taken to reverse the change.

Trial Locations (1)

15213

UPMC Presbyterian Hospital, Pittsburgh

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

lead

University of Pittsburgh

OTHER

NCT06042413 - Prediction and Prevention of Postoperative Mortality and Morbidity | Biotech Hunter | Biotech Hunter