Prevention of Delirium With Light in the Intensive Care Unit (PreDeLight-ICU)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Delirium	Other: Circadian light	Not Applicable

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Prevention of Delirium With Light in the Intensive Care Unit
Study Start Date :	July 2013
Estimated Primary Completion Date :	November 2016
Estimated Study Completion Date :	November 2016

Arms and Interventions

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Arm	Intervention/treatment
No Intervention: Standard light; In this arm patients receive standard lightening conditions
Experimental: Ciradian light; In this arm patients receive artificial ceiling light (circadian light) at the bedside.	Other: Circadian 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.

Outcome Measures

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Primary Outcome Measures :

1. Prevalence of delirium [ Time Frame: 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 Outcome Measures :

1. Delirium prevalence [ Time Frame: 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)
2. Severity of delirium [ Time Frame: 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)
3. Duration of delirium [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
4. Prevalence of subsyndromal delirium (SSD) [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
5. Severity of anxiety [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
6. Cognitive Dysfunction [ Time Frame: ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge ]
7. Post-Traumatic Stress Disorder (PTSD) [ Time Frame: 6 and 12 months after hospital discharge ]
8. Sleep quality [ Time Frame: In the night, starting 48 hours after ICU admission ]
9. ICU length of stay [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
10. Duration of mechanical ventilation [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
11. Hospital length of stay [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
12. Level of sedation [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
13. Pain level [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
14. Amount of administered opioids [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
15. Amount of administered benzodiazepines [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
16. Amount of administered sedatives [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
17. Amount of administered antipsychotics [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
18. Mortality [ Time Frame: ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge ]
19. Light levels (lux) Light levels (lux) [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
20. Light frequencies [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
21. Noise levels (decibel) [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Center of Sleep Medicine, Campus Charité Mitte, Charité - Universitaetsmedizin
Berlin, Germany, 10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Study Director:	Claudia Spies, MD, Prof.	Dept. of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - Universitaetsmedizin Berlin

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Claudia Spies, Univ.-Prof. Dr. Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT01727375 History of Changes
Other Study ID Numbers:	PreDeLight-ICU
First Posted:	November 16, 2012
Last Update Posted:	October 19, 2015
Last Verified:	October 2015

Keywords provided by Claudia Spies, Charite University, Berlin, Germany:

delirium, light, ICU, sleep

Additional relevant MeSH terms:

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations	Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders