DeliriumALADINNCT04246892
Impact of Alarm Reduction on Delirium in ICU
An observational study of Delirium, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Delirium is an acute and fluctuating disturbance of consciousness and can occur in 80% of critically ill patients. Delirium is more frequent in mecanically ventilated patients and is associated with longer hospital stay, increased cognitive impairment and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2020to 23 Feb 2023
- How long will I take part?
- 14 Days
- 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 years and older
- All sexes
- Adult, Older adult
Study population: all patients admitted to ICU, and who meet inclusion criteria
Who may be able to join
- age>18 years, admission to ICU
Who cannot join
- length of stay in ICU<24 hours, moribund patient, deafness, dementia, psychiatric pathology, delirium at admission, acute neurological pathology at admission (stroke, epilepsy, neuro-infection), hepatic encephalopathy, admission for cardiac arrest, admission for voluntary drug intoxication, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Delirium is an acute and fluctuating disturbance of consciousness and can occur in 80% of critically ill patients. Delirium is more frequent in mecanically ventilated patients and is associated with longer hospital stay, increased cognitive impairment and mortality. On the occasion of the change of the monitors in the ICU ward, allowing a total withdrawal of alarms in patients room, this study evaluates the prevalence of delirium before and after the alarm withdrawal. During the first period the patients will be monitored as usual, and during the second period patients will be monitored without alarms ringing in patients room. Delirium will be screened with a validated, clinical tool.
- Conditions
- Delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group before alarm withdrawal | Not described | |
| groupe after alarm withdrawal | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of delirium, according to a ICDSC score>3
prevalence of delirium in each group
Measured: at the end on the ICU stay, an average of 6 days
Secondary outcomes (4)
prevalence of sub-syndromic delirium in each group, according to a ICDSC score<4 and absence of delirium
Measured: at the end on the ICU stay, an average of 6 days
length of mecanical ventilation (days)
Measured: at the end on the ICU stay, an average of 6 days
length of stay in ICU (days)
Measured: at the end on the ICU stay, an average of 6 days
in patients presenting a delirium, duration of delirium (days) defined by the number of days with a ICDSC score>3
Measured: at the end on the ICU stay, an average of 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start3 Feb 2020
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Why it stopped: technical problem, no change of the monitors in the ICU ward
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 89 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lev VOLKOV, Central Hospital, Nancy, France
- Investigators
- Lev VOLKOV, Study director, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246892
- Sponsor's protocol ID
- 2019PI225
- Acronym
- ALADIN
- Status last verified
- Aug 2023
- First submitted
- 20 Jan 2020
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Alarm Reduction on Delirium in ICU
- ClinicalTrials.gov ID
- NCT04246892
- Acronym / sponsor ID
- ALADIN / 2019PI225
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: technical problem, no change of the monitors in the ICU ward
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 29 Jan 2020 (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 an acute and fluctuating disturbance of consciousness and can occur in 80% of critically ill patients. Delirium is more frequent in mecanically ventilated patients and is associated with longer hospital stay, increased cognitive impairment and mortality. On the occasion of the change of the monitors in the ICU ward, allowing a total withdrawal of alarms in patients room, this study evaluates the prevalence of delirium before and after the alarm withdrawal. During the first period the patients will be monitored as usual, and during the second period patients will be monitored without alarms ringing in patients room. Delirium will be screened with a validated, clinical tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group before alarm withdrawal | – | – |
| groupe after alarm withdrawal | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patients admitted to ICU, and who meet inclusion criteria
Key inclusion criteria (1 listed)
- age>18 years, admission to ICU
Key exclusion criteria (1 listed)
- length of stay in ICU<24 hours, moribund patient, deafness, dementia, psychiatric pathology, delirium at admission, acute neurological pathology at admission (stroke, epilepsy, neuro-infection), hepatic encephalopathy, admission for cardiac arrest, admission for voluntary drug intoxication, pregnancy
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
prevalence of delirium, according to a ICDSC score>3
Time frame: at the end on the ICU stay, an average of 6 days
prevalence of delirium in each group
4 secondary outcomes
prevalence of sub-syndromic delirium in each group, according to a ICDSC score<4 and absence of delirium
Time frame: at the end on the ICU stay, an average of 6 days
length of mecanical ventilation (days)
Time frame: at the end on the ICU stay, an average of 6 days
length of stay in ICU (days)
Time frame: at the end on the ICU stay, an average of 6 days
in patients presenting a delirium, duration of delirium (days) defined by the number of days with a ICDSC score>3
Time frame: at the end on the ICU stay, an average of 6 days
Results and safety
The study was stopped early (reason given: technical problem, no change of the monitors in the ICU ward). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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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.
Lev VOLKOV study director
Central Hospital, Nancy, France
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 Delirium, run by Central Hospital, Nancy, France 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 1 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: stopped early, as of the sponsor's last update on 30 Aug 2023. 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?
The study was stopped early (reason given: technical problem, no change of the monitors in the ICU ward). Results are not available in the source record.
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?
prevalence of delirium, according to a ICDSC score>3 (time frame: at the end on the ICU stay, an average of 6 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 30 Aug 2023.