Effectiveness of Delirium Care Protocol After Cardiac Surgery

NCT06268119 | Completed

• 1 other identifier: MustafaKU-SBF-GKS-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery.

Conditions

Delirium, Postoperative

Keywords

delirium; cardiac surgery; nursing

Outcome Measures

Primary Outcomes (1)

• Confusion Assessment Scale in the Intensive Care Unit (CAM-ICU)

  With the application of CAM-ICU, an evaluation is made as "there is delirium" or "there is no delirium". CAM-ICU; It consists of four items including sudden change of consciousness or fluctuation in the patient's level of consciousness, attention assessment, and evaluation of thought organization and level of consciousness. According to this scale, in order for patients to be diagnosed with delirium, the first and second items and one of the third or fourth items must result in favor of delirium.

  Three weeks

Secondary Outcomes (3)

• Glasgow Coma Scale (GCS)

  Three weeks

• Richmond Agitation-Sedation Scale (RASS)

  Three weeks

• Information Assessment Form for Postoperative Delirium (Pretest-Posttest)

  One week

Study Arms (2)

Control group (standard clinical care)

NO INTERVENTION

Control group receiving standard care administered by doctors and nurses for delirium management in the intensive care unit

Intervention group (care with protocol)

EXPERIMENTAL

The intervention group received care in line with the postoperative delirium prevention, diagnosis and intervention protocol after the delirium training given by the researcher to intensive care unit nurses.

Other: training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium.

Interventions

training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium. OTHER

The intervention group received care in line with the postoperative delirium prevention, diagnosis and intervention protocol after the delirium training given by the researcher to intensive care unit nurses.

Intervention group (care with protocol)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the study,
• Being 18 years or older,
• Ability to speak and communicate in Turkish,
• Having undergone cardiac surgery and being on the first postoperative day,
• Richmond Agitation and Sedation Scale (RASS) score of -3 and above,
• Having a Glasgow Coma Scale (GCS) score of 8 and above,
• Not having a serious psychiatric or neurological diagnosis,
• No serious visual or auditory problems

You may not qualify if:

• Undergoing surgeries other than cardiac surgery (such as abdominal endovascular aneurysm repair, thoracic endovascular aneurysm repair, deep vein thrombosis, peripheral artery disease, carotid endarterectomy),
• Previous cardiac surgery,
• Postponing or canceling the surgery,
• No preoperative admission to the cardiovascular surgery service and no emergency surgery.

Sponsors & Collaborators

• Gonul Kara Soylemez: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Center, 07000, Turkey (Türkiye)

Location

Related Publications (6)

• Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.

  PMID: 11445689 BACKGROUND

• Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.

  PMID: 12421743 BACKGROUND

• Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594.

  PMID: 28187050 BACKGROUND

• Allen SR, Frankel HL. Postoperative complications: delirium. Surg Clin North Am. 2012 Apr;92(2):409-31, x. doi: 10.1016/j.suc.2012.01.012.

  PMID: 22414419 BACKGROUND

• Hshieh TT, Inouye SK, Oh ES. Delirium in the Elderly. Clin Geriatr Med. 2020 May;36(2):183-199. doi: 10.1016/j.cger.2019.11.001.

  PMID: 32222295 BACKGROUND

• Soylemez GK, Bulut H. The effectiveness of postoperative delirium prevention, diagnosis, and intervention protocol in patients monitored in the intensive care unit after cardiac surgery: a quasi-experimental study. BMC Nurs. 2024 Dec 18;23(1):904. doi: 10.1186/s12912-024-02547-y.

  PMID: 39695628 DERIVED

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Gonul Kara Soylemez, MD

  Mustafa Kemal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor

Model Details: The control group received standard care. The intervention group received care in line with postoperative delirium prevention, diagnosis, and intervention.

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: March 6, 2023
• Primary Completion: May 15, 2023
• Study Completion: May 22, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)