Post-operative DeliriumNCT06510140
Interest in Combining Intraoperative ElectroEncephaloGram (EEG) With Assessment of Frailty to Predict Postoperative Delirium in Patients Aged >75 Years Undergoing Major Non-cardiac Surgery
An observational study of Post-operative Delirium, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Post-operative delirium (POD) is known to be independently associated with pre-operative frailty, pre-operative cognitive status and per-operative ElectroEncephaloGram (EEG). However, no study has focused on the impact of these pre- and peri-operative outcomes on the prediction of Post-operative delirium (POD). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Post-operative Delirium
- What is being tested?
- Detection of the Post-operative delirium (POD)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2024to Oct 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients older than 75 yo, undergoing a major non-cardiac surgery under general anesthesia will be included.
Who may be able to join
- Patients of 75 yo or more undergoing a major non-cardiac surgery
Who cannot join
- Patients of less than 75 yo
- Cardiac surgery
- Minor surgery
- Opposition to the study protocol
- Presence of a delirium prior to the surgery
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Saint Etienne
Saint-Etienne, 42055
Nory ELHADJENE, MD Jr
Romane CHAPUIS, resident
About this study
Post-operative delirium (POD) is known to be independently associated with pre-operative frailty, pre-operative cognitive status and per-operative ElectroEncephaloGram (EEG). However, no study has focused on the impact of these pre- and peri-operative outcomes on the prediction of Post-operative delirium (POD). Therefore, this study has been designed to assess the performance of a new score that includes pre-operative frailty, and per-operative ElectroEncephaloGram (EEG) in predicting post-operative delirium.
- Conditions
- Post-operative Delirium
- Being tested
- Detection of the Post-operative delirium (POD)
- Keywords
- Post-operative delirium, Frailty, General Anesthesia, Electroencephalogram, Electroencephalography, Older patients, Clinical frailty scale, Major non-cardiac surgery
- Medical subject headings
- Emergence Delirium, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of the Post-operative delirium (POD)Behavioural
Detection of the early Post-operative delirium (POD) to assess the performance of a new composite score with pre-operative frailty, and per-operative ElectroEncephaloGram (EEG).
| Study group | Role | What they receive |
|---|---|---|
| Post-operative delirium (POD) arm (experimental group) | Patients who present a post-operative delirium according to the 3D-CAM within 48h Receives: Behavioral: Detection of the Post-operative delirium (POD) | |
| No Post-operative delirium (POD) arm (control group) | Patients who do not present a post-operative delirium according to the 3D-CAM within 48h Receives: Behavioral: Detection of the Post-operative delirium (POD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of an early Post-operative delirium (POD)
Investigation of an early Post-operative delirium (POD), with Confusion Assessment Method (CAM) criteria, 9-question test which assesses the presence, severity and fluctuation of nine clinical features of delirium, on a scale from 0 to 19. Higher scores indicate more severe delirium.
Measured: Hour : 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start15 May 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative DeliriumStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- 55 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nory ELHADJENE, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510140
- Sponsor's protocol ID
- IRBN482024/CHUSTE
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest in Combining Intraoperative ElectroEncephaloGram (EEG) With Assessment of Frailty to Predict Postoperative Delirium in Patients Aged >75 Years Undergoing Major Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT06510140
- Acronym / sponsor ID
- IRBN482024/CHUSTE
- Conditions
- Post-operative Delirium
- Keywords
- Post-operative delirium, Frailty, General Anesthesia, Electroencephalogram, Electroencephalography, Older patients, Clinical frailty scale, Major non-cardiac surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Jul 2024 (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.
Post-operative delirium (POD) is known to be independently associated with pre-operative frailty, pre-operative cognitive status and per-operative ElectroEncephaloGram (EEG). However, no study has focused on the impact of these pre- and peri-operative outcomes on the prediction of Post-operative delirium (POD). Therefore, this study has been designed to assess the performance of a new score that includes pre-operative frailty, and per-operative ElectroEncephaloGram (EEG) in predicting post-operative delirium.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-operative delirium (POD) arm (experimental group) | – | Behavioral: Detection of the Post-operative delirium (POD)Patients who present a post-operative delirium according to the 3D-CAM within 48h |
| No Post-operative delirium (POD) arm (control group) | – | Behavioral: Detection of the Post-operative delirium (POD)Patients who do not present a post-operative delirium according to the 3D-CAM within 48h |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients older than 75 yo, undergoing a major non-cardiac surgery under general anesthesia will be included.
Key inclusion criteria (1 listed)
- Patients of 75 yo or more undergoing a major non-cardiac surgery
Key exclusion criteria (5 listed)
- Patients of less than 75 yo
- Cardiac surgery
- Minor surgery
- Opposition to the study protocol
- Presence of a delirium prior to the surgery
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 |
|---|---|---|
| Detection of the Post-operative delirium (POD)Detection of the early Post-operative delirium (POD) to assess the performance of a new composite score with pre-operative frailty, and per-operative ElectroEncephaloGram (EEG). | Behavioural | No Post-operative delirium (POD) arm (control group), Post-operative delirium (POD) arm (experimental group) |
Primary outcome
Onset of an early Post-operative delirium (POD)
Time frame: Hour : 48
Investigation of an early Post-operative delirium (POD), with Confusion Assessment Method (CAM) criteria, 9-question test which assesses the presence, severity and fluctuation of nine clinical features of delirium, on a scale from 0 to 19. Higher scores indicate more severe delirium.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Post-operative Delirium
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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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.
Nory ELHADJENE, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Post-operative Delirium, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 1 inclusion and 5 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 22 Jul 2024. 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 France. 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 Nory ELHADJENE, MD ((0)4 77 12 03 88 ext. +33, Nory.ELHADJENE@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of an early Post-operative delirium (POD) (time frame: Hour : 48). 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 22 Jul 2024.