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

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.

Study Overview

• Status: Withdrawn
• Conditions: Delirium
• Intervention / Treatment: Other: Circadian light

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Claudia Spies, MD, Prof., Dept. of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - Universitaetsmedizin Berlin

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ANTICIPATED): November 1, 2016
• Study Completion (ANTICIPATED): November 1, 2016

Study Registration Dates

• First Submitted: July 4, 2012
• First Submitted That Met QC Criteria: November 12, 2012
• First Posted (ESTIMATE): November 16, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 19, 2015
• Last Update Submitted That Met QC Criteria: October 16, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: delirium, light, ICU, sleep
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: PreDeLight-ICU