Understanding how cognitive impairment affects recovery after spine surgery in older patients
Cognition and the Immunology of Postoperative Outcomes
This study is trying to see how memory and thinking problems in older patients affect their recovery after spine surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04792983 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between cognitive impairment and postoperative outcomes in older surgical patients, specifically those undergoing elective spine surgery. The researchers hypothesize that immune system dysfunction may explain why cognitive impairment is a strong predictor of postoperative complications. The study will involve 600 participants aged 65 and older, who will be evaluated preoperatively to assess their cognitive status and immune response. By analyzing these factors, the study seeks to uncover the immunological mechanisms that contribute to postoperative morbidity in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 65 and older who are scheduled for elective spine surgery and have an ASA physical status classification of I-III.
Not a fit: Patients with a history of stroke, brain tumors, autoimmune disorders, or those on medications that significantly impact inflammation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of postoperative complications in older patients with cognitive impairment.
How similar studies have performed: While the specific approach of linking cognitive impairment and immune dysfunction in postoperative outcomes is novel, related studies have shown that cognitive status can significantly impact recovery in older surgical patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 65 years of age * American Society of Anesthesiologists (ASA) physical status of I-III * Scheduled for elective spine surgery. Exclusion Criteria: * History of stroke (not including transient ischemic attacks, or TIAs) * History of brain tumor * History of autoimmune disorders * Medications likely to significantly impact inflammation (e.g. steroids) * Current infection * Uncorrected vision or hearing impairment * limited use of the dominant hand (limited ability to draw) * inability to speak, read, or understand English.
Where this trial is running
Boston, Massachusetts
- Brigham & Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Gregory J Crosby, MD — Brigham & Women's Hospital; Harvard Medical School
- Study coordinator: Gregory J Crosby, MD
- Email: gcrosby@bwh.harvard.edu
- Phone: 617-732-7398
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.