Prevention of Delirium With Light in the Intensive Care Unit - Full Text View

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:

MedlinePlus related topics: Delirium

U.S. FDA Resources

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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ 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 5 days ] [ Designated as safety issue: No ]


Estimated Enrollment:	96
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.

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Center of Sleep Medicine, Campus Charité Mitte, Charité - Universitaetsmedizin	Active, not recruiting
Berlin, Germany, 10117
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charité - Universitaetsmedizin	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.
Sub-Investigator: Isabelle Chaix, MD

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:	October 13, 2014
Health Authority:	Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:


delirium, light, ICU, sleep

Additional relevant MeSH terms:


Delirium Confusion Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders	Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015

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