Delirium
Conditions
Keywords
delirium, light, ICU, sleep
Brief summary
The purpose of this multicenter randomised controlled trial is to investigate if circadian light at the patients bedside (using Philips HealWell system, CE marked)significantly reduces prevalence of delirium in mechanically ventilated intensive care unit patients.
Detailed description
Patients, who are randomly assigned to the Lightening arm will have the circadian light for the whole ICU stay. Light levels at the patients bedside will be measured continuously: embedded light sensors provide irradiance and luminous lux recordings in red, green, and blue color bands and a white light measurement in lux
Interventions
OTHERCircadian light
Artificial ceiling lighting throughout the day will be provided by the Philips HealWell system, CE marked, which is able to deliver varying light levels and warmer or cooler light according to the time of the day (circadian light). Emergency or examination lighting can be set on demand as circumstances require. Lighting conditions at the patients bedside will be characterized by transformations on the time-series of light levels as measured by a luxmeter. The following metrics will be used for lighting characterization in a period of 24h: mean levels of bright and dark periods, contrast between bright and dark periods, clustering of bright and dark periods, and circadian variation.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients with age 18 years and above * Intensive Care Unit stay ≥ 48 hours * Invasive mechanical ventilation or not invasive mechanical ventilation (with positive ventilation pressure \>6hours/day and highflow \>30 litres) on the day of Intensive Care Unit admission
Exclusion criteria
* Patients with a history Intensive Care Unit stay during the actual hospital stay * Patients with delirium on the day of Intensive Care Unit admission * Patients with psychiatric diseases * Patients with a history of stroke and known cognitive dysfunctions * Participation in other clinical studies 10 days before study inclusion and during the study period * Psychiatric disease * History of stroke with known residual cognitive deficits * History of Asystolia or pulseless electric activity with cardiopulmonary resuscitation during entire hospital stay * Analphabetism * Unability of German language use * Anacusis or Hypoacusis with hearing aid device, Amaurosis * Allergies to any ingredient of the electrode fixing material * Lacking willingness to save and hand out data within the study * Accommodation in an institution due to an official or judicial order * The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time * Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of delirium | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | Dekirium will be measured with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of delirium | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | Severity of delirium will be measured with the help of the Intensive Care Delirium Screening Checklist (ICDSC) |
| Duration of delirium | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
| Prevalence of subsyndromal delirium (SSD) | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
| Severity of anxiety | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
| Cognitive Dysfunction | ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge | — |
| Post-Traumatic Stress Disorder (PTSD) | 6 and 12 months after hospital discharge | — |
| Sleep quality | In the night, starting 48 hours after ICU admission | — |
| ICU length of stay | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
| Duration of mechanical ventilation | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
| Hospital length of stay | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks | — |
| Delirium prevalence | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | In this case, delirium will be measured with the help of the Intensive care Delirium Screening Checklist (ICDSC) |
| Pain level | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
| Amount of administered opioids | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
| Amount of administered benzodiazepines | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
| Amount of administered sedatives | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
| Amount of administered antipsychotics | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
| Mortality | ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge | — |
| Light levels (lux) Light levels (lux) | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
| Light frequencies | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
| Noise levels (decibel) | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
| Level of sedation | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days | — |
Countries
Germany
Outcome results
None listed