Impact of Alarm Reduction on Delirium in ICU

Delirium Clinical Trial

— ALADIN  

Official title:

Impact of Alarm Reduction on Delirium in ICU

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04246892
• Other study ID #: 2019PI225
• Status: Terminated
• Start date: February 3, 2020
• Est. completion date: February 23, 2023

Study information

• Verified date: August 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	length of mecanical ventilation (days)		at the end on the ICU stay, an average of 6 days
Secondary	length of stay in ICU (days)		at the end on the ICU stay, an average of 6 days
Secondary	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