Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT05875220

Conditions

Identify Postoperative Delirium Using Exhaled Gas Patterns

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

No intervention

Study Details

Brief summary:

This study involves collecting exhaled breath containing hundreds of volatile organic compounds (VOCs) that are present in very low quantity (parts per billion). VOCs in the exhaled gase carry information to indicate individual's risk for Postoperative Delirium and its severity. Our long-term objectives are to identify breathomic patterns for prediction, early detection, and stratification of POD during pre- and post-operative phases.

Conditions

Identify Postoperative Delirium Using Exhaled Gas Patterns

Study ID

NCT05875220

Start date

Nov 2, 2023

Status verified date

Mar, 2024

Completion date

Nov 30, 2025

Anticipated

Primary completion date

Jul 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

No intervention

No intervention

Primary outcome measure

  • To determine whether patients with POD have a pattern of exhaled VOCs that is different from patients without POD [ Time Frame: July 2023-October 2024 ]
  • To determine whether the exhaled gas pattern is associated with Alzheimer's Disease-related biomarkers in the blood [ Time Frame: July 2023-October 2024 ]

Central Contacts and Locations

Central contacts

Zhiyi Z MD [zzuo]

434.982.4307ZZ3C@uvahealth.org

Zunaira Arbab

za4b@uvahealth.org

Locations

University of Virginia Medical Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Zhiyi Zuo

434.982.4307zz3c@uvahealth.org

More Information

Sponsor

University of Virginia

Last update posted

Mar 27, 2025

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-03-27.