Intensive Care Unit DeliriumNCT06279390
PRE-DELIRIC Prediction Model Plus SMART Care to Reduce the Incidence of Delirium in ICU Patients
An observational study of Intensive Care Unit Delirium, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Delirium is a severe acute brain dysfunction characterised by sudden confusion, inattention and fluctuating level of consciousness, which mainly affects intubated intensive care patients. It increases the risk of self-extubation, prolongs ICU stay and increases mortality. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Intensive Care Unit Delirium
- How many people
- 381 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jun 2023to 30 Oct 2023
- 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 18 to 99 years
- All sexes
- Adult, Older adult
Study population: The inclusion criteria encompass patients admitted to a surgical ICU in Taipei, Taiwan, from January 2021 to March 2023.
Who may be able to join
- 1. SICU patients are over 18 years old. 2. received surgery intervention
Who cannot join
- Clinical diagnosis of mental disorders
- Underwent neurosurgical procedures,
- Discharged from the ICU within 24 hours of admission
- Transitioned to active life support withdrawal or "comfort care only" within 24 hours of ICU admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of PRE-DELIRIC-Guided SMART/SmART Care in Reducing Delirium Incidence Among Surgical Intensive Care Unit Patients
Delirium is a severe acute brain dysfunction characterised by sudden confusion, inattention and fluctuating level of consciousness, which mainly affects intubated intensive care patients. It increases the risk of self-extubation, prolongs ICU stay and increases mortality. The incidence of delirium in ICUs varies, with approximately 33.3% of patients affected, and rates of new-onset and pre-existing delirium range from 4% to 89%. Accurate diagnosis is challenging, with 60-80% of patients remaining undiagnosed. Early detection is critical for intervention and improved outcomes.
To address these issues, the PREdiction of DELIRium (PRE-DELIRIC) model incorporates 10 risk factors and predicts delirium within 24 hours of ICU admission, allowing risk stratification into low to very high risk categories. It recalibrates predictive values with a sensitivity of 91.3% and specificity of 64.4% using a cut-off score of 27%. However, its integration into delirium management is underexplored. Delirium risk stratification supports efficient resource allocation, cost control, workload reduction and ethical care, while promptly identifying high-risk patients.
In this study, Investigators evaluate the integration of the PRE-DELIRIC model into a comprehensive delirium management approach called PRE-DELIRIC-guided SMART/SmART care. SMART care includes improving familiarity, assessing pain and anxiety, reducing equipment discomfort and cognitive stimulation. Patients with PRE-DELIRIC scores >30% receive SMART care and multidisciplinary involvement, based on the American Delirium Society.
- Conditions
- Intensive Care Unit Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of delirium
The incidence of delirium which was assessed by each shift primary ICU nurse by using the ICDSC.
Measured: duration of ICU stay (postoperative 30 days)
Secondary outcomes (5)
duration of ventilator use
duration of ventilator use
Measured: duration of ICU stay( (postoperative 30 days)
rate of unplanned self-extubation
indicates the proportion of patients who unintentionally remove their endotracheal tubes (Yes/No)
Measured: duration of intubation( (postoperative 30 days)
day of physical restraint
day of physical restraint
Measured: duration of ICU stay (postoperative 30 days)
level of mobility
level 0-10 of mobility
Measured: duration of ICU stay (postoperative 30 days)
cumulative dose of sedatives
Sedatives cumulative drugs include midazolam, propofol and dexmedetomidine record 24hours
Measured: duration of ICU stay (postoperative 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start8 Jun 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit DeliriumStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Ling Hsiao, Master, Principal investigator, National Taiwan University HospitalMan-Ling Wang, Doctor, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279390
- Sponsor's protocol ID
- 202305126RINC
- Status last verified
- Jun 2023
- First submitted
- 12 Nov 2023
- Last updated
- 28 Feb 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of PRE-DELIRIC-Guided SMART/SmART Care in Reducing Delirium Incidence Among Surgical Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT06279390
- Acronym / sponsor ID
- 202305126RINC
- Conditions
- Intensive Care Unit Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 28 Feb 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.
Delirium is a severe acute brain dysfunction characterised by sudden confusion, inattention and fluctuating level of consciousness, which mainly affects intubated intensive care patients. It increases the risk of self-extubation, prolongs ICU stay and increases mortality. The incidence of delirium in ICUs varies, with approximately 33.3% of patients affected, and rates of new-onset and pre-existing delirium range from 4% to 89%. Accurate diagnosis is challenging, with 60-80% of patients remaining undiagnosed. Early detection is critical for intervention and improved outcomes.
To address these issues, the PREdiction of DELIRium (PRE-DELIRIC) model incorporates 10 risk factors and predicts delirium within 24 hours of ICU admission, allowing risk stratification into low to very high risk categories. It recalibrates predictive values with a sensitivity of 91.3% and specificity of 64.4% using a cut-off score of 27%. However, its integration into delirium management is underexplored. Delirium risk stratification supports efficient resource allocation, cost control, workload reduction and ethical care, while promptly identifying high-risk patients.
In this study, Investigators evaluate the integration of the PRE-DELIRIC model into a comprehensive delirium management approach called PRE-DELIRIC-guided SMART/SmART care. SMART care includes improving familiarity, assessing pain and anxiety, reducing equipment discomfort and cognitive stimulation. Patients with PRE-DELIRIC scores >30% receive SMART care and multidisciplinary involvement, based on the American Delirium Society.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The inclusion criteria encompass patients admitted to a surgical ICU in Taipei, Taiwan, from January 2021 to March 2023.
Key inclusion criteria (1 listed)
- 1. SICU patients are over 18 years old. 2. received surgery intervention
Key exclusion criteria (4 listed)
- Clinical diagnosis of mental disorders
- Underwent neurosurgical procedures,
- Discharged from the ICU within 24 hours of admission
- Transitioned to active life support withdrawal or "comfort care only" within 24 hours of ICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the incidence of delirium
Time frame: duration of ICU stay (postoperative 30 days)
The incidence of delirium which was assessed by each shift primary ICU nurse by using the ICDSC.
5 secondary outcomes
duration of ventilator use
Time frame: duration of ICU stay( (postoperative 30 days)
rate of unplanned self-extubation
Time frame: duration of intubation( (postoperative 30 days)
day of physical restraint
Time frame: duration of ICU stay (postoperative 30 days)
level of mobility
Time frame: duration of ICU stay (postoperative 30 days)
cumulative dose of sedatives
Time frame: duration of ICU stay (postoperative 30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Intensive Care Unit Delirium
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Not yet recruitingEarly Phase 1
reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
Sleep, Circadian Dysregulation
Not yet recruitingEarly Phase 1
Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle
Sleep, Delirium
RecruitingPhase 4
Lemborexant for Sleep and Delirium Prevention in Elderly ICU Patients
Sleep Disturbance, Delirium
Recruiting
Neurosteer Bedside Monitoring System
Delirium, Sedation
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.
Wei Ling Hsiao, Master principal investigator
National Taiwan University Hospital
Man-Ling Wang, Doctor study director
National Taiwan University Hospital
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 Intensive Care Unit Delirium, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 28 Feb 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of delirium (time frame: duration of ICU stay (postoperative 30 days)). 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 28 Feb 2024.