Prevention of Delirium With Light in the Intensive Care Unit
Not Applicable
Withdrawn
- Conditions
- Delirium
- Interventions
- Other: Circadian light
- Registration Number
- NCT01727375
- Lead Sponsor
- Charite University, Berlin, Germany
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ciradian light Circadian light In this arm patients receive artificial ceiling light (circadian light) at the bedside.
- Primary Outcome Measures
Name Time Method Prevalence of delirium 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)
- Secondary Outcome Measures
Name Time Method Delirium prevalence 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 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 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 Pain level Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days Level of sedation 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
Trial Locations
- Locations (1)
Center of Sleep Medicine, Campus Charité Mitte, Charité - Universitaetsmedizin
🇩🇪Berlin, Germany