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TerminatedNCT04246892ALADINUpdated Aug 30, 2023

Impact of Alarm Reduction on Delirium in ICU

An observational study in Delirium, sponsored by Central Hospital, Nancy, France. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by Central Hospital, Nancy, France · Observational

Why this study was terminated
technical problem, no change of the monitors in the ICU ward
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
89
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Delirium

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In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 89 is below the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

all patients admitted to ICU, and who meet inclusion criteria

Inclusion criteria

  • age>18 years, admission to ICU

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
89 participants (actual)
Target follow-up
14 Days
Patient registry
Yes

Groups and cohorts

  • group before alarm withdrawal
  • groupe after alarm withdrawal
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What researchers measure

Primary outcomes

  1. prevalence of delirium, according to a ICDSC score>3

    prevalence of delirium in each group

    Time frame: at the end on the ICU stay, an average of 6 days

Secondary outcomes

  1. 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

  2. length of mecanical ventilation (days)

    Time frame: at the end on the ICU stay, an average of 6 days

  3. length of stay in ICU (days)

    Time frame: at the end on the ICU stay, an average of 6 days

  4. 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

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Study locations

1 site
  • CHRU Nancy
    Nancy, 54000, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04246892
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Lev VOLKOV (Principal Investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
Jan 29, 2020
Start date
Feb 3, 2020
Primary completion
Feb 23, 2023
Completion
Feb 23, 2023
Last update
Aug 30, 2023

Study contacts

Lev VOLKOV
study director · Central Hospital, Nancy, France

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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