Risk Factors for Delirium in Critically Ill Surgical Patients

• ClinicalTrials.gov Identifier: NCT03050021
• Recruitment Status: Completed
• First Posted: February 10, 2017
• Last Update Posted: February 10, 2017
• Sponsor: Suk-Kyung
• Information provided by (Responsible Party): Suk-Kyung, Asan Medical Center

Study Description

Brief Summary:

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.

Condition or disease
Delirium; Intensive Care Unit Syndrome

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 Design

• Study Type: Observational
• Actual Enrollment: 251 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Risk Factors for Delirium in Critically Ill Surgical Patients
• Actual Study Start Date: April 1, 2013
• Actual Primary Completion Date: August 30, 2013
• Actual Study Completion Date: August 30, 2015

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Prevelance of delirium [ Time Frame: with in 6month in SICU ]
   Analyses were performed to delirium prevelance of SICU Patients

Secondary Outcome Measures :

1. Risk factors associated with delirium [ Time Frame: with in 6month in SICU ]
   Analyses were performed to compare patient, disease, treatment and environment-related factors

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

Asan Medical Center

Seoul, Korea, Republic of, 05505

Sponsors and Collaborators

Suk-Kyung

Investigators

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

More Information

Publications of Results:

Dubois MJ, Bergeron N, Dumont M, Dial S, Skrobik Y. Delirium in an intensive care unit: a study of risk factors. Intensive Care Med. 2001 Aug;27(8):1297-304.

Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62.

Pisani MA, Araujo KL, Van Ness PH, Zhang Y, Ely EW, Inouye SK. A research algorithm to improve detection of delirium in the intensive care unit. Crit Care. 2006;10(4):R121.

Pisani MA, Kong SY, Kasl SV, Murphy TE, Araujo KL, Van Ness PH. Days of delirium are associated with 1-year mortality in an older intensive care unit population. Am J Respir Crit Care Med. 2009 Dec 1;180(11):1092-7. doi: 10.1164/rccm.200904-0537OC. Epub 2009 Sep 10.

Hsieh SJ, Ely EW, Gong MN. Can intensive care unit delirium be prevented and reduced? Lessons learned and future directions. Ann Am Thorac Soc. 2013 Dec;10(6):648-56. doi: 10.1513/AnnalsATS.201307-232FR. Review.

Rapp CG, Mentes JC, Titler MG. Acute confusion/delirium protocol. J Gerontol Nurs. 2001 Apr;27(4):21-33; quiz 62-3.

Thomason JW, Shintani A, Peterson JF, Pun BT, Jackson JC, Ely EW. Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non-ventilated patients. Crit Care. 2005 Aug;9(4):R375-81. Epub 2005 Jun 1.

Hunt JM. The cardiac surgical patient's expectations and experiences of nursing care in the intensive care unit. Aust Crit Care. 1999 Jun;12(2):47-53.

Peterson JF, Pun BT, Dittus RS, Thomason JW, Jackson JC, Shintani AK, Ely EW. Delirium and its motoric subtypes: a study of 614 critically ill patients. J Am Geriatr Soc. 2006 Mar;54(3):479-84.

Irish JT. Deciphering the physician-older patient interaction. Int J Psychiatry Med. 1997;27(3):251-67. Review.

Gustafson Y, Berggren D, Brännström B, Bucht G, Norberg A, Hansson LI, Winblad B. Acute confusional states in elderly patients treated for femoral neck fracture. J Am Geriatr Soc. 1988 Jun;36(6):525-30.

Micek ST, Anand NJ, Laible BR, Shannon WD, Kollef MH. Delirium as detected by the CAM-ICU predicts restraint use among mechanically ventilated medical patients. Crit Care Med. 2005 Jun;33(6):1260-5.

Kamdar BB, Needham DM, Collop NA. Sleep deprivation in critical illness: its role in physical and psychological recovery. J Intensive Care Med. 2012 Mar-Apr;27(2):97-111. doi: 10.1177/0885066610394322. Epub 2011 Jan 10.

Gabor JY, Cooper AB, Crombach SA, Lee B, Kadikar N, Bettger HE, Hanly PJ. Contribution of the intensive care unit environment to sleep disruption in mechanically ventilated patients and healthy subjects. Am J Respir Crit Care Med. 2003 Mar 1;167(5):708-15.

Bross MH, Tatum NO. Delirium in the elderly patient. Am Fam Physician. 1994 Nov 1;50(6):1325-32. Review.

• Responsible Party: Suk-Kyung, Associate Professor in General Surgery, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT03050021
• Other Study ID Numbers: 2014-0251
• First Posted: February 10, 2017
• Last Update Posted: February 10, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Suk-Kyung, Asan Medical Center:

Delirium; Intensive care unit

Additional relevant MeSH terms:

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders