Prevention of Delirium With Light in the Intensive Care Unit

Delirium Clinical Trial

— PreDeLight-ICU  

Official title:

Prevention of Delirium With Light in the Intensive Care Unit

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01727375
• Other study ID #: PreDeLight-ICU
• Status: Withdrawn
• Phase: N/A
• First received: July 4, 2012
• Last updated: October 16, 2015
• Start date: July 2013
• Est. completion date: November 2016

Study information

• Verified date: October 2015
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium

Intervention

Other:
• Circadian light
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.

Locations

Country	Name	City	State
Germany	Center of Sleep Medicine, Campus Charité Mitte, Charité - Universitaetsmedizin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Delirium prevalence	In this case, delirium will be measured with the help of the Intensive care Delirium Screening Checklist (ICDSC)	Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Severity of delirium	Severity of delirium will be measured with the help of the Intensive Care Delirium Screening Checklist (ICDSC)	Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Duration of delirium		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Prevalence of subsyndromal delirium (SSD)		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Severity of anxiety		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Cognitive Dysfunction		ICU admission, ICU discharge, 6 months after hospital discharge, 12 months after ICU discharge	No
Secondary	Post-Traumatic Stress Disorder (PTSD)		6 and 12 months after hospital discharge	No
Secondary	Sleep quality		In the night, starting 48 hours after ICU admission	No
Secondary	ICU length of stay		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Duration of mechanical ventilation		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Hospital length of stay		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 4 weeks	No
Secondary	Level of sedation		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Pain level		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Amount of administered opioids		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Amount of administered benzodiazepines		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Amount of administered sedatives		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Amount of administered antipsychotics		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Mortality		ICU discharge, hospital discharge, 6 months after hospital discharge, 12 months after hospital discharge	No
Secondary	Light levels (lux) Light levels (lux)		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Light frequencies		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No
Secondary	Noise levels (decibel)		Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 5 days	No