Influence of Light Therapy on Confusion in Patients at the Intensive Care Unit

NCT01343433 | Unknown

• 1 other identifier: D-3101-4
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Our purpose of this study is to determine whether bright light therapy is effective for reducing the incidence and the duration of delirium compared to the usual treatment in patients at the Intensive Care Unit. Our hypothesis is that bright light therapy is effective for reducing the incidence and duration of delirium in patients at the Intensive Care Unit Patients will be assigned to a chamber with or without bright light therapy. This assignment is based on occupation of ICU beds and availability of nurses and is therefore independent from patients characteristics. Patients will be included following the inclusion criterion and exclusion criteria. Patients assigned to a chamber with bright light therapy will receive light therapy for three hours in the morning, from eight o'clock till eleven o'clock. The Confusion Assessment Method-score (CAM-score) and the Richmond Agitation Sedation Scale-score (RASS-score) will be performed three times at one day by ICU nurses, this is according to the existing routine. Besides this, an extra CAM-score and a clinical assessment will be performed once a day by a trained non-clinician, to determine the presence of delirium. The use of sedatives, haldol and fixation will be registered to determine the occurrence, duration and severity of delirium. Eventually the most important outcomes will be the clinical assessment of the patients, the CAM-score and the use of haldol. The primary outcome of this study is the duration of delirium, defined in number of days.

Conditions

Delirium; Intensive Care Unit Syndrome

Keywords

Delirium; Intensive Care Unit Syndrome; Bright light therapy; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Duration of delirium, defined in days

  The primary outcome of this study will be the duration of delirium, defined in number of days. This will be derived from the clinical assessments and CAM-scores, performed by the trained non-clinician.

  After 10 weeks

Secondary Outcomes (8)

• Incidence of delirium in the patient group receiving bright light therapy and in the group receiving environmental light

  After 10 weeks

• CAM-scores of the ICU nurses

  After 10 weeks

• Dosage of haloperidol use in delirious patients receiving bright light therapy and those receiving environmental light

  After 10 weeks

• Duration of haldol use in delirious patients receiving bright light therapy and those receiving environmental light

  After 10 weeks

• Mortality of delirious patients in the ICU and in the hospital, comparing those who receive bright light therapy with those who receive environmental light

  After 10 weeks

Study Arms (2)

Control group

Chamber allocation will determine which patient receives bright light therapy. We selected four patient chambers at the Intensive Care Unit, each with the capacity of two patient beds. In two chambers patients will receive bright light therapy. Patients in the other two rooms are only exposed to environmental light

Treatment group (bright light therapy)

Chamber allocation will determine which patient receives bright light therapy. We selected four patient chambers at the Intensive Care Unit, each with the capacity of two patient beds. In two chambers patients will receive bright light therapy. During our study, light therapy will be applied with instrument 'Litepod' (manufactured by Goodlite, Donker Curtiusstraat 7/407, Amsterdam), which gives an intensity of 10000 lux at a distance of 22 centimetres.Patients will receive bright light therapy for three hours in the morning, from eight o'clock till eleven o'clock.

Eligibility Criteria

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

Study Population

All patients of 18 years and older who will be admitted to the Intensive Care Unit of the Onze Lieve Vrouwe Gasthuis, Amsterdam can be included in the study. This is a medical surgical level three ICU with 24 beds. There are over 90 specialised ICU nurses laborious in this ICU. An average of 1500 patients a year is admitted, of which 750 from the cardiothoracic surgical department.

You may not qualify if:

• Psychiatric comorbidity: bipolar disorder
• The use of an antipsychotic drug in the home environment
• Participation in this study during a previous admission to the ICU
• Temporary or permanent loss of total vision

Sponsors & Collaborators

• Onze Lieve Vrouwe Gasthuis: lead

Study Sites (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1090 HM, Netherlands

RECRUITING

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• J.I van der Spoel, MD

  Onze Lieve Vrouwe Gasthuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J.I van der Spoel

CONTACT

003120-5993007; j.i.vanderspoel@olvg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: April 28, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 28, 2011

Record last verified: 2011-04

Locations

NL (1)