Clinical Trial: Dynamic Light Application to Prevent ICU Acquired Delirium

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Dynamic Light Application to Prevent ICU Acquired Delirium

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 ho

Detailed Summary:

STUDY DESIGN This is a prospective randomized, single centre trial. The proposed starting date is 01-july- 2011 and the duration of the study will be 15 months.

All ICU patients who are expected to have an ICU stay of more than 24 hours are potential eligible. On ICU admission, patients will be screened for eligibility. The patients' demographics, patients' health status, medication use, APACHE II score, SOFA score and admission diagnosis will be reported at baseline. Before recruitment and enrollment in the study, each patient and/or relative will be given full explanation of the study and will be informed that they are free to discontinue their participation in the study at any time.

When considered eligible, patients will be given a unique patient number in consecutive order and will be assigned to the treatment corresponding with this number. Patients will be randomized in a one-on-one fashion according to a computer generated randomization list between Standard Care and Standard Care + DLA. The randomization list will be kept at the data co-ordination centre.

All of the 20 patient rooms on the 2 ICU wards are equipped with a special lighting system. This lighting system can offer the standard basic lighting in the patient room, with a set intensity and light colour, or the DL setting which offers changing light conditions depending on the time of the day, following a rhythmic pattern. In addition, all rooms have a basic low-intensity orientation light, which is turned on during night-time in all rooms.

The switch between the two modes is regulated centrally on a control panel that is located in the nursing station and cannot be altered in the patient-room

1.1 Standard Ca
Sponsor: Jeroen Bosch Ziekenhuis

Current Primary Outcome: delirium outcome [ Time Frame: duration of ICU stay(average duration 5 days) ]

Original Primary Outcome: incidence of delirium at ICU stay [ Time Frame: 01-07-2011 01-10-2012 ]

Current Secondary Outcome:

• ICU length-of-stay and ICU mortality [ Time Frame: duration of ICU stay, (average duration 5 days) ]
  ICU length-of-stay and ICU mortality
• duration of mechanical ventilation [ Time Frame: duration of ICU stay (average duration 5 days) ]
• Hospital length-of-stay and hospital mortality [ Time Frame: duration of hospital stay (average duration 14 days) ]
• serum levels of inflammatory markers and markers of brain damage [ Time Frame: duration of ICU stay (average duration 5 days) ]
  when patients are considered to be at high risk of developing ICU acquired delirium ( using a validated scoring system) blood samples will be drawn on days 1, 3, 5, 7, 14, 21, and 28 after inclusion in the study and stored at -80 degrees until analysis.
• urinary levels of markers of circadian rhythm [ Time Frame: duration of ICU stay (average duration 5 days) ]
  in a subgroup of long-stay ICU patients 3-hour urinary samples of cortisol and melatonin will taken during 24 hours to determine the circadian rhythm and the possible effect of DLA on this rhythm
• data of Health-related Quality of Life (HrQoL) questionnaires [ Time Frame: during ICU stay and 3, 6 and 12 months after ICU discharge ]
  3 and 6 months after ICU discharge, a validated HrQoL will be sent to patients homes to assess their QoL after the ICU stay and to detect differences between the DLA and reference group
• Delirium-free days without coma in 28 days [ Time Frame: 28 days ]
  To assess whether Dynamic Light not only influences incidence of delirium, but also duration of delirium, 28-day delirium free days without coma is used as a marker of duration of delirium. Patients who leave the ICU with a delirium (defined as a positive CAM-ICU score within 3 days of ICU discharge) will be followed on the wards using nurse charts and the delirium observation scale (DOS) to assess duration of delirium after ICU discharge

Original Secondary Outcome: Hospital and ICU LOS and hospital mortality [ Time Frame: 01-07-2011 01-10-2012 ]

Dates:
Date Received: January 11, 2011
Date Started: July 2011
Date Completion:
Last Updated: October 14, 2013
Last Verified: October 2013