Prevention of Delirium With Light in the Intensive Care Unit

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Prevention of Delirium With Light in the Intensive Care Unit

Conditions
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Delirium

Intervention / Treatment
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* Other: Circadian light


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard light<br>In this arm patients receive standard lightening conditions | |
| Experimental: Ciradian light<br>In this arm patients receive artificial ceiling light (circadian light) at the bedside. | Other: Circadian light<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delirium, light, ICU, sleep