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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00507481
Other study ID # 4627
Secondary ID
Status Completed
Phase N/A
First received July 24, 2007
Last updated June 3, 2008
Start date January 2006
Est. completion date September 2007

Study information

Verified date June 2008
Source University of Turin, Italy
Contact n/a
Is FDA regulated No
Health authority Italy: National Institute of Health
Study type Observational

Clinical Trial Summary

The aim of this study was to investigate the relationship between sleep disturbances and delirium in surgical ICU patients. The study set up to test the hypothesis that the occurrence of delirium is associated to the alteration of sleep quality and quantity observed in the critically ill patients.


Description:

Sleep disorders are an important clinical entity affecting outcome in respiratory, cardiovascular, metabolic and psychiatric disorders and exacting a potentially significant toll on patients at both a personal and socio-economic level.Delirium is a common organ dysfunction in the critically ill patients characterized by an acute onset of impaired cognitive function [REF] associated with prolonged ICU and hospital stay, nosocomial pneumonia, and death.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Adult, postsurgical patients who needed mechanical ventilation for more than 48 hr admitted to the general ICU

Exclusion Criteria:

- Defined a priori

- Were history of chronic dementia, psychosis, mental retardation, stroke syndrome or other primary neurologic disease

- Patient refusal to participate

- Alcohol and drug abuse.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Italy ICU University S.G.Battista Hospital Turin
Italy Intensive care Unit S.giovanni Battista Hospital Turin

Sponsors (1)

Lead Sponsor Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

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