|- candidate number||6108|
|- NTR Number||NTR1913|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-jul-2009|
|- Secondary IDs||Sleep in ICU |
|- Public Title||Nursing environment and sleep in Intensive Care Unit patients.|
|- Scientific Title||Nursing environment and sleep in Intensive Care Unit patients.|
|- hypothesis||Sleep (quality and quantity) is beter in ICU patients when they are nursed in a single room compared to nursing in a 'open' ICU. |
|- Healt Condition(s) or Problem(s) studied||Sleep in intensive care unit, Nursing enviroment, Polysomnography|
|- Inclusion criteria||1. Cardio-sugrical patients presenting in the pre-surgical out-patients clinic;|
2. Informed consent.
|- Exclusion criteria||1. Severe sleeping disorders at baseline;|
2. Alcohol abuse at baseline;
3. Chronic benzodiazepine at baseline;
4. Any cerebral complication during surgery or post-surgery, including delirium, stroke and an epileptic insult.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-sep-2009|
|- planned closingdate||1-sep-2010|
|- Target number of participants||20|
|- Interventions||Change of nursing enviroment: |
1. Multi patient, 'open' ICU;
2. Single room ICU.
|- Primary outcome||Sleep quality/quantity as measured with polysomnography.|
|- Secondary outcome||Subjective sleep perception (questoinnaire).|
|- Timepoints||1. First questionnaire one week pre-surgery;|
2. Polysomnography 24 hours post-surgery;
3. Second questionnaire 72 hours post-surgery.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. A.J.C Slooter|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A.J.C Slooter|
|- Sponsor/Initiator ||University medical Center Utrecht (UMCU), Department of Intensive Care|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU)|
|- Brief summary||Sleep disruption in the Intensive Care Unit (ICU) seems to be associated with an increase in morbidity and mortality. Most patients have difficulties sleeping in the ICU due to the continuous light and sound of other patients and the care-workers. In 2010 the University Medical Center Utrecht (UMCU) will open a completely new ICU in which all patients are nursed in single rooms, in contrast to the existing situation were patients are nursed on large, common wards. With the use of polysomnography we will compare the sleep quality and quantity of patients in relation to nursing environment.
|- Main changes (audit trail)|
|- RECORD||17-jul-2009 - 10-okt-2009|