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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Onze Lieve Vrouwe Gasthuis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier:
NCT01343433
First received: April 25, 2011
Last updated: April 26, 2011
Last verified: April 2011
  Purpose

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.


Condition
Delirium
Intensive Care Unit Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Bright Light Therapy on Delirium in Patients at the Intensive Care Unit: a Pilot-study

Resource links provided by NLM:


Further study details as provided by Onze Lieve Vrouwe Gasthuis:

Primary Outcome Measures:
  • Duration of delirium, defined in days [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Incidence of delirium in the patient group receiving bright light therapy and in the group receiving environmental light [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]
  • CAM-scores of the ICU nurses [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]
    The Confusion Assessment Method-ICU is the most accurate diagnostic instrument to detect delirium in hospitalized patients and is the only instrument validated for detecting delirium in mechanically ventilated patients. These scores are already determined three times at one day by Intensive Care nurses.

  • Dosage of haloperidol use in delirious patients receiving bright light therapy and those receiving environmental light [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]
    The dosage of haldol use will be registered to determine the presence and duration of delirium

  • Duration of haldol use in delirious patients receiving bright light therapy and those receiving environmental light [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]
    The duration of haldol use will be registered to determine the presence and duration of delirium

  • Mortality of delirious patients in the ICU and in the hospital, comparing those who receive bright light therapy with those who receive environmental light [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]
    We are interested in variables that could be influenced by the presence of delirium, including mortality.

  • Duration of mechanical ventilation in delirious patients receiving bright light therapy and those receiving environmental light [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]
    We are interested in variables that could be influenced by the presence of delirium, including duration of mechanical ventilation

  • Duration of admission of delirious patients in the ICU and in the hospital, comparing those who receive bright light therapy with those who receive environmental light [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]
    We are interested in variables that could be influenced by the presence of delirium, including the duration of admission

  • Duration of admission in the ICU and in the hospital, comparing those who receive bright light therapy with those who receive environmental light [ Time Frame: After 10 weeks ] [ Designated as safety issue: No ]
    We are interested in variables that could be influenced by the presence of delirium, including the duration of admission


Estimated Enrollment: 70
Study Start Date: March 2011
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

Intensive Care patients experience severe alterations of sleep. They may develop a circadian rhythm sleep disorder, characterized by an irregular sleep/wake pattern. The presence of abnormal sleep/wake cycles may be a risk factor for delirium, which would link it to higher morbidity, mortality and longer ICU stay. Bright light therapy is the treatment of choice for circadian rhythm sleep disorders and may be helpful in handling delirium. The objective of this study is to determine whether bright light therapy is effective for reducing the incidence and duration of delirium in the Intensive Care Unit.

This is a prospective, single center cohort investigation by witch the influence of bright light therapy on the incidence and duration of delirium will be examined and compared with environmental light. This study will take place at the ICU of the OLVG, a level three ICU with 24 beds in a teaching hospital.

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. 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. Patients diagnosed with bipolar disorder will be excluded from participation. Other exclusion criteria are the use of an antipsychotic drug in the home environment, temporary or permanent loss of total vision and participation in this study during a previous admission to the Intensive Care Unit.

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.

At the Intensive Care Unit of the Onze Lieve Vrouwe Gasthuis, Amsterdam, light therapy is used by nurses for optimizing the light intensity in their work environment, for their own well being and for the prevention of sleep disturbances. The light therapy is also randomly used for the treatment of Intensive Care patients, though the effectiveness and functionality have not been a subject of investigation. Our purpose of this study is to determine whether bright light therapy is effective for reducing the incidence and the duration of delirium in the Intensive Care Unit. The primary outcome of this study is the duration of delirium, defined in number of days. This will be derived from the clinical assessments and the CAM-scores, performed by the trained non-clinician.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion criterion:

  • Age: a minimum age of 18 years

Exclusion criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343433

Contacts
Contact: J.I van der Spoel 003120-5993007 j.i.vanderspoel@olvg.nl

Locations
Netherlands
Onze Lieve Vrouwe Gasthuis Recruiting
Amsterdam, Noord-Holland, Netherlands, 1090 HM
Contact: J I van der Spoel, MD    003120-5993007    j.i.vanderspoel@olvg.nl   
Principal Investigator: J.I van der Spoel, MD         
Sub-Investigator: W.F Scholtens         
Sub-Investigator: D.S Scheepens, MD         
Sub-Investigator: J.G Lijmer, MD, PhD         
Sponsors and Collaborators
Onze Lieve Vrouwe Gasthuis
Investigators
Principal Investigator: J.I van der Spoel, MD Onze Lieve Vrouwe Gasthuis
  More Information

No publications provided

Responsible Party: J.I. van der Spoel, Onze Lieve Vrouwe Gasthuis
ClinicalTrials.gov Identifier: NCT01343433     History of Changes
Other Study ID Numbers: D-3101-4
Study First Received: April 25, 2011
Last Updated: April 26, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Onze Lieve Vrouwe Gasthuis:
Delirium
Intensive Care Unit Syndrome
Bright light therapy
Intensive Care Unit

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014