Dynamic Light Application to Prevent ICU Acquired Delirium

NCT01274819 | Completed

• 1 other identifier: DLA 2011
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Delirium is a frequently encountered problem in ICU patients and leads to increased morbidity and mortality; Delirium in the ICU is associated with sleep deprivation which is among others caused by a disrupted circadian rhythm; Dynamic Light application aims at restoring a proper circadian rhythm by rhythmically alternating light intensity and has shown beneficial effects in sleep quality. Whether DLA improves sleep quality and reduces delirium incidence in ICU patients is not known Goals/endpoints: To evaluate the feasibility of dynamic light application in the ICU and to study the effects of dynamic light application on the incidence of delirium, duration of mechanical ventilation, the number of ICU and hospital days, and mortality in a mixed population of medical and surgical ICU patients. In a subgroup of patients with a high risk of developing delirium, markers of circadian rhythm, inflammation and brain damage and post ICU HRQoL will be assessed Study design: prospective randomized single centre trial Study population: adult ICU patients \> 18 years old with an expected duration of stay of more than 24 hours Intervention: Patients will be randomized between Standard Care or Standard Care + DLA; When receiving standard care, normal lighting settings will be used in that patient room, which can be controlled by the medical personnel; In the rooms of patients randomized to the DLA group, DL is applied with a changing intensity during the day according to a fixed rhythm, which is regulated centrally. In addition when necessary, an intervention light can be used which can be operated in the patient room. Study parameters/endpoints: incidence of delirium as measured by the CAM-ICU; duration of mechanical ventilation, ICU and total hospital mortality; ICU and hospital LOS; Serum levels of inflammatory markers and markers of brain damage, urinary levels of markers of circadian rhythm, data of HRQoL questionnaires and total light exposure in both groups

Conditions

Delirium; Confusion

Keywords

delirium; confusion

Outcome Measures

Primary Outcomes (1)

• delirium outcome

  This is a composite endpoint of incidence of delirium during ICU stay, 28-day delirium free days (28-DFD) and 28-day ventilator free days (28-VFD)

  duration of ICU stay(average duration 5 days)

Secondary Outcomes (7)

• ICU length-of-stay and ICU mortality

  duration of ICU stay, (average duration 5 days)

• duration of mechanical ventilation

  duration of ICU stay (average duration 5 days)

• Hospital length-of-stay and hospital mortality

  duration of hospital stay (average duration 14 days)

• serum levels of inflammatory markers and markers of brain damage

  duration of ICU stay (average duration 5 days)

• urinary levels of markers of circadian rhythm

  duration of ICU stay (average duration 5 days)

Study Arms (2)

Dynamic light

EXPERIMENTAL

ICU patients exposed to dynamic light during ICU stay

Other: Dynamic Light

Normal Light

NO INTERVENTION

control group is exposed to normal light during ICU stay

Interventions

Dynamic Light OTHER

Dynamic Light Application (DLA) is a light application which exposes the subject in the room to a varying light intensity and light temperature during the day thus mimicking a natural daylight exposure.

Also known as: Philips

Dynamic light

Eligibility Criteria

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

You may qualify if:

• ICU-patients \>18 yrs old
• expected duration of stay \> 24 hrs

You may not qualify if:

• life expectancy of \<48 hrs on ICU admission
• necessity of prolonged deep sedation
• blindness
• inability to speak or understand dutch

Sponsors & Collaborators

• Jeroen Bosch Ziekenhuis: lead

Study Sites (1)

Jeroen Bosch Hospital

's-Hertogenbosch, 5211 nl, Netherlands

Location

Related Publications (41)

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MeSH Terms

Conditions

Delirium; Confusion

Interventions

Dynamic Light Scattering

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scattering, Radiation; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• KS Simons, drs

  Jeroen Bosch Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Drs

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 12, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

NL (1)