1. To evaluate the feasibility and safety of dynamic light application in an Intensive Care facility2. To study the effects of dynamic light application on the incidence of delirium, the number of ICU and hospital days and mortality in a mixed…
ID
Source
Brief title
Condition
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
incidence of delirium as measured by the CAM-ICU
Secondary outcome
ICU and total hospital mortality
ICU and hospital LOS
ventilation duration
Background summary
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
Study objective
1. To evaluate the feasibility and safety of dynamic light application in an
Intensive Care facility
2. To study the effects of dynamic light application on the incidence of
delirium, the number of ICU and hospital days and mortality in a mixed
population of medical and surgical ICU patients
3. To determine whether severity of disease influences treatment effect and
outcome
Study design
prospective randomized single centre trial
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 personel; 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 burden and risks
The extent of the burden is nil for the subjects: as well as the risks
Nieuwstraat 34
5211 NL
NL
Nieuwstraat 34
5211 NL
NL
Listed location countries
Age
Inclusion criteria
ICU patients>18 years old
expected duration of stay on ICU >24 hrs
Exclusion criteria
diagnosis of delirium before admission at ICU
Preexisting cognitive impairment
life expectancy of less than 48 hours on ICU admission
blindness
unability to speak or understand dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | DLA 11 |
CCMO | NL34780.028.10 |