Effectiveness of Delirium Care Protocol After Cardiac Surgery

NCT ID: NCT06268119

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-06

Study Completion Date

2023-05-22

Brief Summary

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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.

Detailed Description

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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".

Conditions

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Delirium, Postoperative

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The control group received standard care. The intervention group received care in line with postoperative delirium prevention, diagnosis, and intervention.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group (standard clinical care)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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training 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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gonul Kara Soylemez

OTHER

Sponsor Role lead

Responsible Party

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Gonul Kara Soylemez

Instructor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gonul Kara Soylemez, MD

Role: PRINCIPAL_INVESTIGATOR

Mustafa Kemal University

Locations

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Antalya Training and Research Hospital

Antalya, Center, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 11445689 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12421743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28187050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22414419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32222295 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39695628 (View on PubMed)

Other Identifiers

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MustafaKU-SBF-GKS-01

Identifier Type: -

Identifier Source: org_study_id

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