CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
intervention bundle (sedation, pain, mobilization and sleep)other
Likely dose
Not stated in record
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Search/NCT02594982
NCT02594982N/ACompleted

DANish DELIrium Study On Neurointensive Care Patients. A Two Phase Intervention Study

Kirsten Moller·interventional·Posted Nov 3, 2015·Updated Oct 4, 2017

In Brief

A clinical study evaluating intervention bundle (sedation, pain, mobilization and sleep) for Acquired Brain Injuries and 2 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 3, 2015
Enrollment StartAug 1, 2015
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.7 years ago

Interventions

intervention bundle (sedation, pain, mobilization and sleep)other

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