Clinical Trial: Prevention of Delirium With Light in the Intensive Care Unit

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Prevention of Delirium With Light in the Intensive Care Unit

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 Summary: 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
Sponsor: Charite University, Berlin, Germany

Current Primary Outcome: Prevalence of delirium [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]

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


Original Primary Outcome: Prevalence of delirium [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]

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


Current Secondary Outcome:

  • Delirium prevalence [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
    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 ]
    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 ]
  • 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 ]
  • Severity of anxiety [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
  • Cognitive Dysfunction [ Time Frame: ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge ]
  • Post-Traumatic Stress Disorder (PTSD) [ Time Frame: 6 and 12 months after hospital discharge ]
  • Sleep quality [ Time Frame: In the night, starting 48 hours after ICU admission ]
  • ICU length of stay [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
  • Duration of mechanical ventilation [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
  • Hospital length of stay [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Level of sedation [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
  • Pain level [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
  • Amount of administered opioids [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
  • Amount of administered benzodiazepines [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
  • Amount of administered sedatives [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
  • Amount of administered antipsychotics [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
  • Mortality [ Time Frame: ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge ]
  • 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 ]
  • Light frequencies [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]
  • Noise levels (decibel) [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days ]


Original Secondary Outcome:

  • Delirium prevalence [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
    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 4 weeks ]
    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 4 weeks ]
  • Prevalence of subsyndromal delirium (SSD) [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Severity of anxiety [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Cognitive Dysfunction [ Time Frame: ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge ]
  • Post-Traumatic Stress Disorder (PTSD) [ Time Frame: 6 and 12 months after hospital discharge ]
  • Sleep quality [ Time Frame: In the night, starting 48 hours after ICU admission ]
  • ICU length of stay [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Duration of mechanical ventilation [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Hospital length of stay [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Level of sedation [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Pain level [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Amount of administered opioids [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Amount of administered benzodiazepines [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Amount of administered sedatives [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Amount of administered antipsychotics [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Mortality [ Time Frame: ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge ]
  • Light levels (lux), Light levels (lux) [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Light frequencies [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]
  • Noise levels (decibel) [ Time Frame: Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks ]


Information By: Charite University, Berlin, Germany

Dates:
Date Received: July 4, 2012
Date Started: July 2013
Date Completion: November 2016
Last Updated: October 16, 2015
Last Verified: October 2015