Clinical trial NCT01727375: Prevention of Delirium With Light in the Intensive Care Unit
Official title: Prevention of Delirium With Light in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Delirium
Keywords: delirium, light, ICU, sleep
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Prevalence of delirium
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Secondary outcomes:
measure: Delirium prevalence
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Severity of delirium
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Duration of delirium
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Prevalence of subsyndromal delirium (SSD)
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Severity of anxiety
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Cognitive Dysfunction
timeFrame: ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge
measure: Post-Traumatic Stress Disorder (PTSD)
timeFrame: 6 and 12 months after hospital discharge
measure: Sleep quality
timeFrame: In the night, starting 48 hours after ICU admission
measure: ICU length of stay
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Duration of mechanical ventilation
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Hospital length of stay
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks
measure: Level of sedation
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Pain level
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Amount of administered opioids
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Amount of administered benzodiazepines
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Amount of administered sedatives
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Amount of administered antipsychotics
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Mortality
timeFrame: ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge
measure: Light levels (lux) Light levels (lux)
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Light frequencies
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
measure: Noise levels (decibel)
timeFrame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center of Sleep Medicine, Campus Charité Mitte, Charité - Universitaetsmedizin
Study officials:
affiliation: Dept. of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - Universitaetsmedizin Berlin
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: