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

Primary Purpose

Delirium

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Circadian light
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring delirium, light, ICU, sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center of Sleep Medicine, Campus Charité Mitte, Charité - Universitaetsmedizin

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard light

Ciradian light

Arm Description

In this arm patients receive standard lightening conditions

In this arm patients receive artificial ceiling light (circadian light) at the bedside.

Outcomes

Primary Outcome Measures

Prevalence of delirium
Dekirium will be measured with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

Secondary Outcome Measures

Delirium prevalence
In this case, delirium will be measured with the help of the Intensive care Delirium Screening Checklist (ICDSC)
Severity of delirium
Severity of delirium will be measured with the help of the Intensive Care Delirium Screening Checklist (ICDSC)
Duration of delirium
Prevalence of subsyndromal delirium (SSD)
Severity of anxiety
Cognitive Dysfunction
Post-Traumatic Stress Disorder (PTSD)
Sleep quality
ICU length of stay
Duration of mechanical ventilation
Hospital length of stay
Level of sedation
Pain level
Amount of administered opioids
Amount of administered benzodiazepines
Amount of administered sedatives
Amount of administered antipsychotics
Mortality
Light levels (lux) Light levels (lux)
Light frequencies
Noise levels (decibel)

Full Information

First Posted
July 4, 2012
Last Updated
October 16, 2015
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01727375
Brief Title
Prevention of Delirium With Light in the Intensive Care Unit
Acronym
PreDeLight-ICU
Official Title
Prevention of Delirium With Light in the Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Study Start Date
July 2013 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
delirium, light, ICU, sleep

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard light
Arm Type
No Intervention
Arm Description
In this arm patients receive standard lightening conditions
Arm Title
Ciradian light
Arm Type
Experimental
Arm Description
In this arm patients receive artificial ceiling light (circadian light) at the bedside.
Intervention Type
Other
Intervention Name(s)
Circadian light
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of delirium
Description
Dekirium will be measured with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Secondary Outcome Measure Information:
Title
Delirium prevalence
Description
In this case, delirium will be measured with the help of the Intensive care Delirium Screening Checklist (ICDSC)
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Title
Severity of delirium
Description
Severity of delirium will be measured with the help of the Intensive Care Delirium Screening Checklist (ICDSC)
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Title
Duration of delirium
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Title
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
Title
Severity of anxiety
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Title
Cognitive Dysfunction
Time Frame
ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge
Title
Post-Traumatic Stress Disorder (PTSD)
Time Frame
6 and 12 months after hospital discharge
Title
Sleep quality
Time Frame
In the night, starting 48 hours after ICU admission
Title
ICU length of stay
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Title
Duration of mechanical ventilation
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Title
Hospital length of stay
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks
Title
Level of sedation
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Title
Pain level
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Title
Amount of administered opioids
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Title
Amount of administered benzodiazepines
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Title
Amount of administered sedatives
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Title
Amount of administered antipsychotics
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Title
Mortality
Time Frame
ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge
Title
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
Title
Light frequencies
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Title
Noise levels (decibel)
Time Frame
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Spies, MD, Prof.
Organizational Affiliation
Dept. of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - Universitaetsmedizin Berlin
Official's Role
Study Director
Facility Information:
Facility Name
Center of Sleep Medicine, Campus Charité Mitte, Charité - Universitaetsmedizin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

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Prevention of Delirium With Light in the Intensive Care Unit

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