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CompletedNCT06268119Updated Feb 20, 2024

Effectiveness of Delirium Care Protocol After Cardiac Surgery

An interventional study of training nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium. in Delirium, Postoperative, sponsored by Gonul Kara Soylemez. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Gonul Kara Soylemez · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Mar 2023, registered Feb 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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. The research was conducted at Antalya Training and Research Hospital between 06.03.2023 and 22.05.2023. The sample of the study consisted of 64 patients who underwent cardiac surgery and met the inclusion criteria. Within the scope of the study, patients were divided into two groups: control (32) and intervention (32). While the patients in the intervention group received care in line with the "Postoperative delirium prevention, diagnosis and intervention protocol", the patients in the control group received routine nursing care for delirium. The data of the study were collected using the Patient Identification Form, Acute Physiological and Chronic Health Evaluation, Glasgow Coma Scale, Richmond Agitation-Sedation Scale, Confusion Assessment Scale in the Intensive Care Unit, Nurse Diagnosis Form, Information Assessment Form for Postoperative Delirium (Pretest-Posttest) and Postoperative Delirium Prevention, Diagnosis and Intervention Protocol Checklist. In the first stage of the study, which consisted of three stages, the incidence of delirium in the control group patients receiving routine nursing care and the delirium diagnosis status of the nurses were determined. In the second stage, nurses were given training on postoperative delirium prevention, diagnosis and intervention protocol, and a preliminary study of the protocol was conducted. In the third phase, which is the last phase, patients in the intervention group received care in line with the "Postoperative Delirium Prevention, Diagnosis and Intervention Protocol".

02

Conditions studied

  • Delirium, Postoperative

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Keywords

  • delirium
  • cardiac surgery
  • nursing
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 64 is below the median of 120 across 599 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

This is the only study on the registry with Gonul Kara Soylemez as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • No intervention
    Control group (standard clinical care)

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

  • Experimental
    Intervention group (care with protocol)

    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

  • Othertraining nurses and caring for patients to prevent, diagnose, and intervene in postoperative delirium.

    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.

06

What researchers measure

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.

    Time frame: Three weeks

Secondary outcomes

  1. Glasgow Coma Scale (GCS)

    It is used to evaluate the patients' state of consciousness. With a scale consisting of three parts: eye opening, motor and verbal response, the patients' response to stimuli in these three areas is evaluated and scored. It is evaluated between three and fifteen points, with fifteen points indicating full consciousness and three points indicating deep coma. In order for CAM-ICU to be applied to patients, the GCS score must be eight or above. If the GCS score is eight or below, the patient is considered to be in a coma and cannot be evaluated.

    Time frame: Three weeks

  2. Richmond Agitation-Sedation Scale (RASS)

    Before starting the delirium evaluation, the state of consciousness (alertness) is first evaluated. RASS takes values between "(+4)" and "(-5)". While the ideal level where the patient is alert and calm is scored as "0" on the scale, positive RASS scores "(+1,+2,+3,+4)" indicate an agitated patient; Negative RASS scores "(-1,-2,-3,-4,-5)" indicate patients who are sedated or in a coma.

    Time frame: Three weeks

  3. Information Assessment Form for Postoperative Delirium (Pretest-Posttest)

    The knowledge assessment form for postoperative delirium (Pretest-Posttest) was developed by researchers by scanning the literature in order to measure the knowledge levels of nurses working in intensive care units before and after training on postoperative delirium. For each item in the form consisting of 30 questions, answers were received from the participants as "True", "False" and "I don't know". "1" point was given for each "True" statement, and "0" point was given for each "False" and "I don't know" statements. The highest score that can be obtained from the test is "30". The form, consisting of items regarding the definition of delirium, risk factors, symptoms, prevention, diagnosis and intervention of delirium, was applied by the researcher to all nurses who attended the training before and after the training.

    Time frame: One week

07

Study locations

1 site
  • Antalya Training and Research Hospital
    Antalya, Center 07000, Turkey
08

References and documents

Publications

  • 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. PubMed 11445689 ↗
  • 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. PubMed 12421743 ↗
  • 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. Erratum In: Eur J Anaesthesiol. 2018 Sep;35(9):718-719. doi: 10.1097/EJA.0000000000000872. PubMed 28187050 ↗
  • 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. PubMed 22414419 ↗
  • 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. PubMed 32222295 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06268119
Lead sponsor
Gonul Kara Soylemez
Responsible party
Gonul Kara Soylemez (Instructor, Mustafa Kemal University) — Sponsor-investigator
First posted
Feb 20, 2024
Start date
Mar 6, 2023
Primary completion
May 15, 2023
Completion
May 22, 2023
Last update
Feb 20, 2024

Study contacts

Gonul Kara Soylemez, MD
principal investigator · Mustafa Kemal University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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