Postoperative DeliriumNCT04736303
The Impact of the Implementation of BIS on the Incidence of Postoperative Delirium
A study testing BIS in people with Postoperative Delirium, run by University of Thessaly at 1 site in Greece.
Trial summary
This study will investigate the incidence of postoperative POD in patients undergoing non cardiac surgery under general anesthesia with and without the implementation of the BIS monitoring.T Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- BIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2021to 1 Apr 2023
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients over 60 years of age
- an American Society of Anesthesiologists (ASA) physical status I to III
- undergoing elective non cardiac surgery under general anaesthesia
- native speakers of the Greek language
- eligible to leave the post-anaesthesia care unit
- an expected in-hospital stay at least 24 hours following surgery
Who cannot join
- refused to participate or sign the informed consent form
- surgery or anaesthesia within the last 30 day
- any prior or current history involving an affliction of the central nervous system
- severe hearing or visual impairment
- psychiatric disorders
- a score less than 5 according the Geriatric Depression Scale (GDS-15)
Show all 12Show fewer
- a score less than 4 for females and less than 2 for males according to the Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
- alcohol consumption less than 35 units/week
- drug dependence
- previous neuropsychological testing
- haemodynamical instability
- peri-procedural desaturation (one or more events of SpO2<80% for more than 2 minutes)
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Univeristy of Thessaly
Larissa, Thessaly, 41110
Eleni Arnaoutoglou, MD, PhD, 2413501370, earnaout@gmail.com
Maria Ntalouka, MD, +306973688099, maria.ntalouka@icloud.com
About this study
Official title: Assessing the Impact of the Implementation of BIS on the Incidence of Postoperative Delirium - A Monocentre Prospective Trial
This study will investigate the incidence of postoperative POD in patients undergoing non cardiac surgery under general anesthesia with and without the implementation of the BIS monitoring.T
Read the detailed description
This study will compare the incidence of POD after elective non cardiac surgery conducted under general anesthesia before and after the implementation of BIS monitoring in our University Hospital.
The POD will be evaluated with the CAM and Nu-DESC tools, which have been adapted for the greek population.
- Conditions
- Postoperative Delirium
- Being tested
- BIS
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BISDevice
The implementation of BIS monitoring
| Study group | Role | What they receive |
|---|---|---|
| POD without BIS | No intervention | Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery, with CAM and Nu-DESC tools. |
| POD with BIS | Active comparator | Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery with the implementation of BIS monitoring, with CAM and Nu-DESC tools. Receives: Device: BIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POD
Assess the incidence of POD with CAM and Nu-DESC tools
Measured: 1st postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Dec 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
- Investigators
- Eleni Arnaoutoglou, MD, PhD, Study chair, University of ThessalyMaria Ntalouka, MD, PhD, Principal investigator, University Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736303
- Sponsor's protocol ID
- POD and BIS
- Status last verified
- Aug 2022
- First submitted
- 2 Oct 2020
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of the Implementation of BIS on the Incidence of Postoperative Delirium - A Monocentre Prospective Trial
- ClinicalTrials.gov ID
- NCT04736303
- Acronym / sponsor ID
- POD and BIS
- Conditions
- Postoperative Delirium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 3 Feb 2021 (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 will investigate the incidence of postoperative POD in patients undergoing non cardiac surgery under general anesthesia with and without the implementation of the BIS monitoring.T
Detailed description
This study will compare the incidence of POD after elective non cardiac surgery conducted under general anesthesia before and after the implementation of BIS monitoring in our University Hospital.
The POD will be evaluated with the CAM and Nu-DESC tools, which have been adapted for the greek population.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POD without BIS | No intervention | –Assessing the incidence of POD in patients under general anethesia for elective non cardiac surgery, with CAM and Nu-DESC tools. |
| POD with BIS | Active comparator | Device: BISAssessing the incidence of POD in patients under general anethesia for elective non cardiac surgery with the implementation of BIS monitoring, with CAM and Nu-DESC tools. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult patients over 60 years of age
- an American Society of Anesthesiologists (ASA) physical status I to III
- undergoing elective non cardiac surgery under general anaesthesia
- native speakers of the Greek language
- eligible to leave the post-anaesthesia care unit
Key exclusion criteria (12 listed)
- refused to participate or sign the informed consent form
- surgery or anaesthesia within the last 30 day
- any prior or current history involving an affliction of the central nervous system
- severe hearing or visual impairment
- psychiatric disorders
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 |
|---|---|---|
| BISThe implementation of BIS monitoring | Device | POD with BIS |
Primary outcome
Incidence of POD
Time frame: 1st postoperative day
Assess the incidence of POD with CAM and Nu-DESC tools
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Delirium
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The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
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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.
Eleni Arnaoutoglou, MD, PhD study chair
University of Thessaly
Maria Ntalouka, MD, PhD principal investigator
University Hospital of Larissa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS in people with Postoperative Delirium, run by University of Thessaly at 1 site in Greece.
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 6 inclusion and 12 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 19 Aug 2022. 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 Greece. 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 Eleni Arnaoutoglou, MD, PhD (+306974301352, earnaout@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of POD (time frame: 1st postoperative day). 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 19 Aug 2022.