Prevention of Delirium With Light in the Intensive Care Unit (PreDeLight-ICU)
This study is not yet open for participant recruitment.
Verified November 2012 by Charite University, Berlin, Germany
Sponsor:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01727375
First received: July 4, 2012
Last updated: November 12, 2012
Last verified: November 2012
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 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 4 weeks ] [ Designated as safety issue: No ]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 4 weeks ] [ Designated as safety issue: No ]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 4 weeks ] [ Designated as safety issue: No ]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 4 weeks ] [ Designated as safety issue: No ]
- Prevalence of subsyndromal delirium (SSD) [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
- Severity of anxiety [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
- Cognitive Dysfunction [ Time Frame: ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge ] [ Designated as safety issue: No ]
- Post-Traumatic Stress Disorder (PTSD) [ Time Frame: 6 and 12 months after hospital discharge ] [ Designated as safety issue: No ]
- Sleep quality [ Time Frame: In the night, starting 48 hours after ICU admission ] [ Designated as safety issue: No ]
- ICU length of stay [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
- Duration of mechanical ventilation [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
- Hospital length of stay [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
- Level of sedation [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
- Pain level [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
- Amount of administered opioids [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
- Amount of administered benzodiazepines [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
- Amount of administered sedatives [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
- Amount of administered antipsychotics [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge ] [ Designated as safety issue: No ]
- Light levels (lux), Light levels (lux) [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
- Light frequencies [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
- Noise levels (decibel) [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 96 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727375
Contacts
| Contact: Claudia Spies, MD, Prof. | +49 (0) 30 450 551 001 | claudia.spies@charite.de |
Locations
| Germany | |
| Asklepios Stadtklinik Bad Tölz GmbH, Deaprtment of Anesthesiology and Intensive Care Medicine | Not yet recruiting |
| Bad Tölz, Germany, 83646 | |
| Contact: Martin Schlott, MD, Dr. +49 8041 1201 anaesthesie.badtoelz@asklepios.com | |
| Principal Investigator: Martin Schlott, MD, Dr. | |
| Sub-Investigator: Markus Niklas, MD, Dr. | |
| Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charité - Universitaetsmedizin | Not yet recruiting |
| Berlin, Germany, 13353 | |
| Contact: Claudia Spies, MD, Prof. +49 (0) 30 450 551 001 claudia.spies@charite.de | |
| Principal Investigator: Claudia Spies, MD, Prof. | |
| Sub-Investigator: Alawi Lütz, MD, Dr. | |
| Sub-Investigator: Björn Weiss, MD, Dr. | |
| Center of Sleep Medicine, Campus Charité Mitte, Charité - Universitaetsmedizin | Not yet recruiting |
| Berlin, Germany, 10117 | |
| Contact: Ingo Fietze, MD, Prof. +49 (0) 30 450 513 120 schlaf.labor@charite.de | |
| Contact: Thomas Penzel, MD, Prof. 49 (0) 30 450 513 013 schlaf.labor@charite.de | |
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
No publications provided
| 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 |
| Study First Received: | July 4, 2012 |
| Last Updated: | November 12, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Charite University, Berlin, Germany:
|
delirium, light, ICU, sleep |
Additional relevant MeSH terms:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013