Organic Compounds and Postoperative Delirum

NCT05875220 | Recruiting

• 2 other identifiers: IRB HSR 230087R21AG083656
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• To determine whether patients with POD have a pattern of exhaled VOCs that is different from patients without POD

  The concentrations of VOCs in the exhaled breath will be tested by the portable GC. A chromatogram, which is made up of a series of chemical detector electrical signals vs recording times, of each breath sample will be generated during the portable GC measurement. The normalized peak areas in the chromatogram will be extracted, representing the VOC concentrations in the exhaled breath. About 350 mL exhaled breath will be needed for each GC test. Exhaled breath will be harvested at 3 points. To determine the chemical identities of the exhaled VOC biomarkers, a small subset of collected breath samples will be analyzed by mounting the portable GC to an mass spectroscopy (MS) in tandem. The breath sample will be collected by a Tedlar bag first before being transferred to the portable GC device for measurement. The GC outlet is connected to the MS via a short transfer line so that the same breath sample is detected simultaneously by the chemical detector in the portable GC and MS.

  July 2023-October 2024

• To determine whether the exhaled gas pattern is associated with Alzheimer's Disease-related biomarkers in the blood

  Blood (5 ml) will be harvested at (1) before the anesthesia induction and (2) at the completion of surgery but before endotracheal extubation, and (3) 24 hours after surgery (the same three time points for harvesting exhaled gases from the 150 participants as described previously). The levels of two types of indices in the blood will be determined. The first group of indices is to reflect amyloid and NFT load. These include Aβ1-42, ratio of Aβ1-42 and Aβ1-40, total tau, P-tau at 181 or 217. These indices will be measured by ELISA. The second group of indices is to indicate neurodegeneration. They are NFL and neurogranin, which will also be measured by ELISA. The measurement of the exhaled VOC concentrations is discussed in previous sections. These concentrations will be correlated with the levels of the above blood indices.

  July 2023-October 2024

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who are 65 years old or older with a spine surgery for at least 2 segments of spine and are anticipated to be hospitalized for 2 days or longer.

You may qualify if:

• 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

You may not qualify if:

• 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
• Difficulty with follow-up or poor compliance serious hearing and vision impairment that affects regular conversation and reading

Sponsors & Collaborators

• University of Virginia: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Exhaled gas and blood sample

Central Study Contacts

Zhiyi Z MD [zzuo]

CONTACT

434.982.4307; ZZ3C@uvahealth.org

Zunaira Arbab

CONTACT

za4b@uvahealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 25, 2023
• Study Start: November 2, 2023
• Primary Completion: July 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 27, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)