DeliriumNCT04042649
Environmental Intervention on Delirious Patients
A study testing environmental intervention in people with Delirium, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The implementation of environmental intervention program reduced the duration of delirium and length of stay at the ICU in critically-ill surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- environmental intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2013to 31 Oct 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with an age of 18 years or older
- who understood the purpose of this study and agreed to participate
- stayed in the SICU for a period of 48 hours or longer
Who cannot join
- who remained unresponsive [defined as the Richmond Agitation-Sedation Scale (RASS) less than -4]
- who could not measure Confusion Assessment Method (CAM-ICU) due to severe visual or hearing disturbance
- who had a history of severe psychiatric or neurologic deficit
- who required an isolation room due to transplantation or immunologic compromise
- who were discharged from ICU within 48 hours
- who were re-admitted to the ICU
- who were less than 18 years old
- who were admitted to the Surgical ICU through another ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Environmental Intervention on Critically-ill Surgical Patients With Delirium
The implementation of environmental intervention program reduced the duration of delirium and length of stay at the ICU in critically-ill surgical patients.
Read the detailed description
Purpose: Delirium occurs among patients in intensive care unit at high rates and increases the risk for morbidity and mortality. The purpose of this study is to investigate the effects of environmental interventions for the prevention of delirium.
Methods: A total of 192 patients who had been admitted to the surgical intensive care unit (SICU) in Asan Medical Center during the pre-intervention period (Jun 2013 to Oct 2013) and the post-intervention period (Jun 2014 to Oct 2014) was enrolled and prospective cohort study was done. The environmental intervention included cognitive assessment, providing orientation and comfortable environment, and a proper sleeping environment. The primary outcomes were the incidence rate of delirium, time of delirium onset, and the duration of delirium.
- Conditions
- Delirium
- Being tested
- environmental intervention
- Keywords
- intensive care unit, critically ill patients, environmental intervention
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
environmental interventionBehavioural
provide environmental intervention (help sleep cycle, provide comfortable environment)
| Study group | Role | What they receive |
|---|---|---|
| pre-intervention | No intervention | Critically ill patients didn't provide environmental intervention (help sleep cycle, provide comfortable environment) |
| post-intervention | Experimental | After providing environmental intervention for critically ill patients Receives: Behavioral: environmental intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence rate of delirium
Measured: 5 month
time to delirium onset
Measured: 5 month
the duration of delirium
Measured: 5 month
Secondary outcomes (5)
the number of days of ventilator use
Measured: 5 month
the length of stay at the SICU
Measured: 5 month
the length of stay at hospital
Measured: 5 month
the rate of re-admission to the SICU
Measured: 5 month
mortality rate.
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Jun 2013
- Primary completion31 Oct 2014
- Study completion31 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suk-Kyung, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042649
- Sponsor's protocol ID
- AsanMC-Delirium
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2019
- Last updated
- 5 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Inouye SK. The dilemma of delirium: clinical and research controversies regarding diagnosis and evaluation of delirium in hospitalized elderly medical patients. Am J Med. 1994 Sep;97(3):278-88. doi: 10.1016/0002-9343(94)90011-6.
PubMed 8092177Holt R, Young J, Heseltine D. Effectiveness of a multi-component intervention to reduce delirium incidence in elderly care wards. Age Ageing. 2013 Nov;42(6):721-7. doi: 10.1093/ageing/aft120. Epub 2013 Aug 26.
PubMed 23978407Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
PubMed 15082703Arenson BG, MacDonald LA, Grocott HP, Hiebert BM, Arora RC. Effect of intensive care unit environment on in-hospital delirium after cardiac surgery. J Thorac Cardiovasc Surg. 2013 Jul;146(1):172-8. doi: 10.1016/j.jtcvs.2012.12.042. Epub 2013 Jan 11.
PubMed 23317943
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Environmental Intervention on Critically-ill Surgical Patients With Delirium
- ClinicalTrials.gov ID
- NCT04042649
- Acronym / sponsor ID
- AsanMC-Delirium
- Conditions
- Delirium
- Keywords
- intensive care unit, critically ill patients, environmental intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 31 Oct 2014 (actual)
- Study completion
- 31 Oct 2014 (actual)
- First posted
- 2 Aug 2019 (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.
The implementation of environmental intervention program reduced the duration of delirium and length of stay at the ICU in critically-ill surgical patients.
Detailed description
Purpose: Delirium occurs among patients in intensive care unit at high rates and increases the risk for morbidity and mortality. The purpose of this study is to investigate the effects of environmental interventions for the prevention of delirium.
Methods: A total of 192 patients who had been admitted to the surgical intensive care unit (SICU) in Asan Medical Center during the pre-intervention period (Jun 2013 to Oct 2013) and the post-intervention period (Jun 2014 to Oct 2014) was enrolled and prospective cohort study was done. The environmental intervention included cognitive assessment, providing orientation and comfortable environment, and a proper sleeping environment. The primary outcomes were the incidence rate of delirium, time of delirium onset, and the duration of delirium.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-intervention | No intervention | –Critically ill patients didn't provide environmental intervention (help sleep cycle, provide comfortable environment) |
| post-intervention | Experimental | Behavioral: environmental interventionAfter providing environmental intervention for critically ill patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- with an age of 18 years or older
- who understood the purpose of this study and agreed to participate
- stayed in the SICU for a period of 48 hours or longer
Key exclusion criteria (8 listed)
- who remained unresponsive [defined as the Richmond Agitation-Sedation Scale (RASS) less than -4]
- who could not measure Confusion Assessment Method (CAM-ICU) due to severe visual or hearing disturbance
- who had a history of severe psychiatric or neurologic deficit
- who required an isolation room due to transplantation or immunologic compromise
- who were discharged from ICU within 48 hours
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 |
|---|---|---|
| environmental interventionprovide environmental intervention (help sleep cycle, provide comfortable environment) | Behavioural | post-intervention |
Primary outcome
the incidence rate of delirium
Time frame: 5 month
time to delirium onset
Time frame: 5 month
the duration of delirium
Time frame: 5 month
5 secondary outcomes
the number of days of ventilator use
Time frame: 5 month
the length of stay at the SICU
Time frame: 5 month
the length of stay at hospital
Time frame: 5 month
the rate of re-admission to the SICU
Time frame: 5 month
mortality rate.
Time frame: 5 month
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 5 Aug 2019.
- Results publication: PubMed 8092177Inouye SK. The dilemma of delirium: clinical and research controversies regarding diagnosis and evaluation of delirium in hospitalized elderly medical patients. Am J Med. 1994 Sep;97(3):278-88. doi: 10.1016/0002-9343(94)90011-6.
- Results publication: PubMed 23978407Holt R, Young J, Heseltine D. Effectiveness of a multi-component intervention to reduce delirium incidence in elderly care wards. Age Ageing. 2013 Nov;42(6):721-7. doi: 10.1093/ageing/aft120. Epub 2013 Aug 26.
- Results publication: PubMed 15082703Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
- Results publication: PubMed 23317943Arenson BG, MacDonald LA, Grocott HP, Hiebert BM, Arora RC. Effect of intensive care unit environment on in-hospital delirium after cardiac surgery. J Thorac Cardiovasc Surg. 2013 Jul;146(1):172-8. doi: 10.1016/j.jtcvs.2012.12.042. Epub 2013 Jan 11.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing environmental intervention in people with Delirium, run by Asan Medical Center at 1 site in South Korea.
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 3 inclusion and 8 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 5 Aug 2019. 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 South Korea. 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 rate of delirium (time frame: 5 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04042649, which also lists 4 linked publications.
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 5 Aug 2019; AzTrials last refreshed its copy on 29 Oct 2026.