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DANish DELIrium Study On Neurointensive Care Patients

NCT02594982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-10-04

No results posted yet for this study

Summary

Abstract Background Studies have shown that delirium in medical and surgical intensive care units (ICUs) increases mortality, length of stay (LOS) as well as the risk of dementia symptoms and cerebral atrophy after discharge. Only few studies have investigated delirium in the neurointensive care unit (N-ICU). Delirium is most often assessed by one of two instruments: Intensive Care Delirium Screening Checklist (ICDSC) or the Confusion Assessment Method for the ICU (CAM-ICU).

Aims

1. To measure the effect of a systematic intervention (sedation, sleep, mobilization and pain) on delirium symptoms in patients with acute acquired brain injury in N-ICU.
2. To validate the ICDSC and CAM-ICU to patients with acute acquired brain injury Method The design of the study is a two-phase interventional trial. Based on a power calculation, 56 patients will be enrolled both in the baseline and the intervention group (n=112).

Part 1: A baseline investigation will be conducted to establish prevalence, duration and type of delirium symptoms in patients with acute acquired brain injury before implementing the intervention bundle.

Part 2: A systematic Intervention protocol will be implemented in the N-ICU. The Intervention elements consist of a sedation, sleep, mobilization and pain treatment regimen based on the newest available evidence.

Enrolled patients will be contacted 12 months after discharge for a follow-up including a quality of life with (EuroQoL-5D) questionnaire, a cognitive test measuring their cognitive end point (Repeatable Battery for Assessment of the Neuropsychological Status) and a short test for dementia symptoms (MMSE, Mini Mental State Examination).

Conditions

  • Acquired Brain Injuries
  • Delirium
  • Acute Brain Injury

Interventions

OTHER

intervention bundle (sedation, pain, mobilization and sleep)

Sedation: Sedation after target RASS Pain: Implementing a pain guideline and CPOT for pain assessment. Mobilization: Implementing a guideline on early mobilization and a daily prescribed mobilization level. Sleep: Implementing a daily quite time and changing procedures to minimize noise during the night

Sponsors & Collaborators

  • Kirsten Moller

    lead OTHER

Principal Investigators

  • Kirsten moeller, professor · Rigshospitalet, 2093

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02594982 on ClinicalTrials.gov