Prevention of Delirium With Light in the Intensive Care Unit

NCT01727375 | Withdrawn

• 1 other identifier: PreDeLight-ICU
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

delirium, light, ICU, sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Delirium prevalence

  Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days

• Severity of delirium

  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

Study Arms (2)

Standard light

NO INTERVENTION

In this arm patients receive standard lightening conditions

Ciradian light

EXPERIMENTAL

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

Other: Circadian light

Interventions

Circadian light OTHER

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.

Ciradian light

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Claudia Spies, MD, Prof.

  Dept. of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - Universitaetsmedizin Berlin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. Claudia Spies

Study Record Dates

• First Submitted: July 4, 2012
• First Posted: November 16, 2012
• Study Start: July 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 19, 2015

Record last verified: 2015-10

Locations

DE (1)