Identifying Postoperative Delirium Using Breath Analysis
Exhaled Volatile Organic Compounds, Phospho-tau and Postoperative
This study is trying to see if analyzing the breath of patients having spine surgery can help predict and understand the risk of confusion after their operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05875220 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect and analyze exhaled breath samples from patients undergoing spine surgery to identify volatile organic compounds (VOCs) that may indicate the risk and severity of postoperative delirium (POD). By utilizing a portable gas chromatography device attached to anesthesia machines, the study seeks to develop a noninvasive method for real-time monitoring of VOCs. The long-term goal is to establish breathomic patterns that can predict and stratify POD during both pre- and post-operative phases, potentially improving patient outcomes. This approach is novel as it focuses on breath analysis, which has not been extensively studied in the context of surgical patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 65 and older who are scheduled for spine surgery involving at least two segments and are expected to be hospitalized for two days or longer.
Not a fit: Patients with severe cardiovascular, respiratory, liver, kidney, or central nervous system diseases, as well as those with a life expectancy of less than three months, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early detection and better management of postoperative delirium, improving recovery and reducing hospital stays for patients.
How similar studies have performed: While this approach of using breath analysis for POD prediction is novel, similar studies in other contexts have shown promise in utilizing VOCs for disease detection.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants who are 65 years old or older with a spine surgery for at least 2 segments of spine * Participants who are anticipated to be hospitalized for 2 days or longer Exclusion Criteria: * Severe cardiovascular, respiratory, liver, kidney, or central nervous system * Diseases and having a life span of less than 3 months * A history of major neurological diseases and psychiatric illness other than AD or ADRD * Alcoholism or drug dependence * Previous inclusion in this study * Difficulty with follow-up or poor compliance serious hearing and vision impairment that affects regular conversation and reading
Where this trial is running
Charlottesville, Virginia
- University of Virginia Medical Center — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Zhiyi Z MD [zzuo]
- Email: ZZ3C@uvahealth.org
- Phone: 434.982.4307
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.