Identify Postoperative Delirium Using Exhaled Gas PatternsNCT05875220
Organic Compounds and Postoperative Delirum
An observational study of Identify Postoperative Delirium Using Exhaled Gas Patterns, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Identify Postoperative Delirium Using Exhaled Gas Patterns
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2023to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Zunaira Arbab contact
United States1 site, 1 recruiting
- Recruiting
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Zhiyi Zuo, 434.982.4307, zz3c@uvahealth.org
About this study
Official title: Exhaled Volatile Organic Compounds, Phospho-tau and Postoperative
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.
Read the detailed description
Post-operative delirium (POD) is a serious clinical syndrome associated with increased mortality and morbidity. Old age and Alzheimer's disease are at an increased risk for developing post-operative delirium. POD occurs in 60% of patients after surgery (ref) and is associated with a poor outcome including longer hospitalization and higher rate of mortality (ref). Although the investigators have methods like AD biomarker blood tests, they are expensive and time-consuming.
This study involves collecting exhaled breath containing hundreds of volatile organic compounds (VOCs) that are present in very low quantity (parts per billion). These VOCs are by-products of metabolic activities in healthy and disease states. VOCs in the exhaled gases, which can be extracted in a noninvasive fashion, carry information to indicate individual's risk for POD and its severity. Real-time monitoring of VOCs could potentially produce point-of-care (POC) breathomic signatures capable of rapid prediction during pre-operative phase, as well as early diagnosis and stratification of POD during post-operative phase. However, there is no study on analyzing exhaled gases of patients with surgery to improve their outcome. In this initial project, the investigators propose to determine whether a portable and fully automated gas chromatography (GC) device, which can be attached to an anesthesia machine circuit, is capable of rapidly detecting exhaled VOCs for POD prediction. Our long-term objectives are to identify breathomic patterns for prediction, early detection, and stratification of POD during pre- and post-operative phases. Such POC monitoring has a great potential not only to be transformative in perioperative managing patients with surgery and allowing for precision treatment, but also to elicit the pathophysiological understanding of POD and accelerate drug development for reducing POD.
The investigators hypothesize that patients with POD have a unique pattern of exhaled VOCs and that this pattern is associated with AD-related biomarkers in the blood.
Aim 1: To determine whether patients with POD have a pattern of exhaled VOCs that is different from patients without POD. The exhaled gases of patients with a major spine surgery will be analyzed by a portable GC with an automated GC data processing pipeline for chromatogram peak feature extractions, including baseline removal, denoising, normalization, peak detection, peak modeling, and chromatogram alignment. The VOC pattern of patients with POD will be compared with that of patients without POD.
Aim 2: To determine whether the exhaled gas pattern is associated with AD-related biomarkers in the blood. AD-related biomarkers in the blood will be measured by ELISA. Correlations between the levels of VOCs that contribute to the pattern changes between patients with POD and patients without POD and the levels of AD related biomarkers will be performed. Dysfunction of possible metabolic pathways in patients with POD may be indicated by VOCs that have changes in those patients
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: July 2023-October 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start2 Nov 2023
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Identify Postoperative Delirium Using Exhaled Gas PatternsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Zhiyi Zuo, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875220
- Sponsor's protocol ID
- IRB HSR 230087
- Other IDs
- R21AG083656
- Status last verified
- Mar 2024
- First submitted
- 26 Apr 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Volatile Organic Compounds, Phospho-tau and Postoperative
- ClinicalTrials.gov ID
- NCT05875220
- Acronym / sponsor ID
- IRB HSR 230087
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Post-operative delirium (POD) is a serious clinical syndrome associated with increased mortality and morbidity. Old age and Alzheimer's disease are at an increased risk for developing post-operative delirium. POD occurs in 60% of patients after surgery (ref) and is associated with a poor outcome including longer hospitalization and higher rate of mortality (ref). Although the investigators have methods like AD biomarker blood tests, they are expensive and time-consuming.
This study involves collecting exhaled breath containing hundreds of volatile organic compounds (VOCs) that are present in very low quantity (parts per billion). These VOCs are by-products of metabolic activities in healthy and disease states. VOCs in the exhaled gases, which can be extracted in a noninvasive fashion, carry information to indicate individual's risk for POD and its severity. Real-time monitoring of VOCs could potentially produce point-of-care (POC) breathomic signatures capable of rapid prediction during pre-operative phase, as well as early diagnosis and stratification of POD during post-operative phase. However, there is no study on analyzing exhaled gases of patients with surgery to improve their outcome. In this initial project, the investigators propose to determine whether a portable and fully automated gas chromatography (GC) device, which can be attached to an anesthesia machine circuit, is capable of rapidly detecting exhaled VOCs for POD prediction. Our long-term objectives are to identify breathomic patterns for prediction, early detection, and stratification of POD during pre- and post-operative phases. Such POC monitoring has a great potential not only to be transformative in perioperative managing patients with surgery and allowing for precision treatment, but also to elicit the pathophysiological understanding of POD and accelerate drug development for reducing POD.
The investigators hypothesize that patients with POD have a unique pattern of exhaled VOCs and that this pattern is associated with AD-related biomarkers in the blood.
Aim 1: To determine whether patients with POD have a pattern of exhaled VOCs that is different from patients without POD. The exhaled gases of patients with a major spine surgery will be analyzed by a portable GC with an automated GC data processing pipeline for chromatogram peak feature extractions, including baseline removal, denoising, normalization, peak detection, peak modeling, and chromatogram alignment. The VOC pattern of patients with POD will be compared with that of patients without POD.
Aim 2: To determine whether the exhaled gas pattern is associated with AD-related biomarkers in the blood. AD-related biomarkers in the blood will be measured by ELISA. Correlations between the levels of VOCs that contribute to the pattern changes between patients with POD and patients without POD and the levels of AD related biomarkers will be performed. Dysfunction of possible metabolic pathways in patients with POD may be indicated by VOCs that have changes in those patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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
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.
To determine whether the exhaled gas pattern is associated with Alzheimer's Disease-related biomarkers in the blood
Time frame: July 2023-October 2024
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zunaira Arbab contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Identify Postoperative Delirium Using Exhaled Gas Patterns, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiyi Z MD [zzuo] (434.982.4307, ZZ3C@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.