Impact of Alarm Reduction on Delirium in ICU (ALADIN)

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 Overview

• Status: Terminated
• Conditions: Delirium

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • CHRU Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

all patients admitted to ICU, and who meet inclusion criteria

Description

Inclusion Criteria:

• age>18 years, admission to ICU

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
group before alarm withdrawal
groupe after alarm withdrawal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of delirium, according to a ICDSC score>3	prevalence of delirium in each group	at the end on the ICU stay, an average of 6 days

Secondary Outcome Measures

Outcome Measure	Time Frame
prevalence of sub-syndromic delirium in each group, according to a ICDSC score<4 and absence of delirium	at the end on the ICU stay, an average of 6 days
length of mecanical ventilation (days)	at the end on the ICU stay, an average of 6 days
length of stay in ICU (days)	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	at the end on the ICU stay, an average of 6 days

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Director: Lev VOLKOV, Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 2019PI225

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No