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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard light | No Intervention | In this arm patients receive standard lightening conditions | |
| Ciradian light | Experimental | In this arm patients receive artificial ceiling light (circadian light) at the bedside. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circadian light | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of delirium | Dekirium will be measured with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium prevalence | In this case, delirium will be measured with the help of the Intensive care Delirium Screening Checklist (ICDSC) | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days |
| Severity of delirium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Spies, MD, Prof. | Dept. of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - Universitaetsmedizin Berlin | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Sleep Medicine, Campus Charité Mitte, Charité - Universitaetsmedizin | Berlin | State of Berlin | 10117 | Germany |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
Severity of delirium will be measured with the help of the Intensive Care Delirium Screening Checklist (ICDSC) |
| Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days |
| 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 |
| Level of sedation | Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days |
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |