Risk Factors for Delirium in Critically Ill Surgical Patients

February 8, 2017 updated by: Suk-Kyung
Delirium is characterized by changes in mental status, inattension, disorganized thinking, and altered consciousness. Prevalence of delirium in critically ill patients has varied from 20~80% depending on the severity of illness. Despite its high prevalence, delirium is often under-recognized by clinicians due to the difficulties in diagnosis and no interest. Delirium is associated with increased mechanical ventilation days, hospital length of stay, and mortality. The purpose of this study is to analyze the prevalence of delirium and risk factors for delirium in critically ill surgical patients.

Study Overview

Status

Completed

Detailed Description

The investigators performed a prospective cohort study involving the patients admitted to surgical ICU between april 2013 and august 2013.

The included patients were assessed independently by trained ICU nurses using the confusion Assessment Method for the ICU (CAM-ICU). The patients were recorded general characteristics, disease-related factors, and treatment and environment-related factors. Data were analyzed by SPSS 12.0 software, using t-test, Fisher's exact test and logistic regression.

Study Type

Observational

Enrollment (Actual)

251

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Admitted to the surgical ICU from April to August 2013 and had the ability to express themselves verbally or nonverbally.

Description

Inclusion Criteria:

  1. Above RASS -3 paitent
  2. Verbally or nonverbally communication possible patients

Exclusion Criteria:

  1. Under age 18
  2. Neurological disorder e.g.) Brain injury, dementia and traumatic brain injury
  3. Readmitted to ICU
  4. History of delirium
  5. Transplanted; isolation is required

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Delirium positive
delirium patients in critically ill surgical patients
Delirium negative
non delirium patients in critically ill surgical patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevelance of delirium
Time Frame: with in 6month in SICU
Analyses were performed to delirium prevelance of SICU Patients
with in 6month in SICU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors associated with delirium
Time Frame: with in 6month in SICU
Analyses were performed to compare patient, disease, treatment and environment-related factors
with in 6month in SICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Suk-kyung Hong, Ph.D, University of Ulsan College of Medicine. Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

August 30, 2013

Study Completion (Actual)

August 30, 2015

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Actual)

February 10, 2017

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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