Prevention of Delirium With Light in the Intensive Care Unit (PreDeLight-ICU)
This study has been withdrawn prior to enrollment.
Sponsor:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01727375
First Posted: November 16, 2012
Last Update Posted: October 19, 2015
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
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Purpose
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 | Intervention |
|---|---|
| Delirium | Other: Circadian light |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Claudia Spies, Charite University, Berlin, Germany:
Primary Outcome Measures:
- 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:
- 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)
- 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)
- Duration of delirium [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
- 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 ]
- Severity of anxiety [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
- Cognitive Dysfunction [ Time Frame: ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge ]
- Post-Traumatic Stress Disorder (PTSD) [ Time Frame: 6 and 12 months after hospital discharge ]
- Sleep quality [ Time Frame: In the night, starting 48 hours after ICU admission ]
- ICU length of stay [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
- Duration of mechanical ventilation [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
- Hospital length of stay [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
- Level of sedation [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
- Pain level [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
- Amount of administered opioids [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
- Amount of administered benzodiazepines [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
- Amount of administered sedatives [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
- Amount of administered antipsychotics [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
- Mortality [ Time Frame: ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge ]
- 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 ]
- Light frequencies [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
- Noise levels (decibel) [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
| Enrollment: | 0 |
| Study Start Date: | July 2013 |
| Estimated Study Completion Date: | November 2016 |
| Estimated Primary Completion Date: | November 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
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
Eligibility
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727375
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
| 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 Submitted: | July 4, 2012 |
| 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 |