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Evaluation of Risk Factors of Sleep Quality in Intensive Care Unit

This study has been completed.
Sponsor:
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00507481
First received: July 24, 2007
Last updated: June 3, 2008
Last verified: June 2008
History of Changes
  Purpose

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.


Condition
Sleep Disorders
Delirium

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Risk Factors of Sleep Quality in Critically Ill Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Turin, Italy:

Study Start Date: January 2006
Study Completion Date: September 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507481

Locations
Italy
ICU University S.G.Battista Hospital
Turin, Italy, 10126
Intensive care Unit S.giovanni Battista Hospital
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Investigators
Study Director: Marco V Ranieri, Professor University of Turin
  More Information

No publications provided

Responsible Party: Trompeo Anna Chiara, University of Turin
ClinicalTrials.gov Identifier: NCT00507481     History of Changes
Other Study ID Numbers: 4627
Study First Received: July 24, 2007
Last Updated: June 3, 2008
Health Authority: Italy: National Institute of Health

Keywords provided by University of Turin, Italy:
Sleep
ICU
Delirium
Post surgical ventilated patients
ICU patients

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

ClinicalTrials.gov processed this record on June 17, 2013