Impact of Alarm Reduction on Delirium in ICU

NCT04246892 | Terminated

• 1 other identifier: 2019PI225
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

group before alarm withdrawal

groupe after alarm withdrawal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all patients admitted to ICU, and who meet inclusion criteria

You may qualify if:

• age\>18 years, admission to ICU

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lev VOLKOV

  Central Hospital, Nancy, France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 29, 2020
• Study Start: February 3, 2020
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

FR (1)