Development of Perioperative Delirium Prediction Model

NCT06685263 | Not Yet Recruiting DMC

• 1 other identifier: 2024-15/3
• Study Type: observational
• Target: 770
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative delirium is an acute organic brain dysfunction that is commonly observed following cardiovascular surgery. It presents with acute and fluctuating changes in the level of consciousness, resulting in impaired cognitive function and perception. The incidence of delirium following cardiac surgery has been reported to range from 11.4% to 55%. In light of the challenges associated with treating delirium once it has manifested, it is imperative to prioritise the early recognition and prevention of this condition. The objective of this study was to develop a perioperative delirium risk prediction model for patients undergoing cardiovascular surgery.

Conditions

Cardiovascular Surgery

Keywords

cardiovascular surgery; delirium; prediction model

Outcome Measures

Primary Outcomes (1)

• Development of a delirium risk prediction model

  The objective of this study is to develop a perioperative delirium risk prediction model for patients undergoing cardiovascular surgery.

  1 year

Study Arms (2)

Development group

The development group comprises 385 individuals. Following the data collection process, the independent risk factors for the development of delirium will be identified through statistical analysis. A delirium prediction model will then be developed based on the identified risk factors.

Behavioral: Group 1

Validation group

The validation group comprises 385 individuals. The delirium prediction model, constructed using the data from the development group, will be validated by testing the data from the validation group. This process will enable the evaluation of the model's suitability and calibration for predicting delirium.

Behavioral: Group 2

Interventions

Group 1 BEHAVIORAL

The development group comprises 385 individuals. Following the data collection phase of the development group, the independent risk factors for the onset of delirium will be identified through statistical analysis. A delirium prediction model will then be constructed using the identified risk factors.

Development group

Group 2 BEHAVIORAL

The validation group comprises 385 individuals. The delirium prediction model created using the data from the development group will be validated by testing the data from the validation group. This will enable the evaluation of the model's fit and calibration in predicting delirium.

Validation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In order to be eligible for inclusion in the study, the patient must be at least 18 years of age and must have undergone a surgical procedure on the cardiovascular system. Furthermore, the subject must not have any mental or sensory impairment, psychiatric diagnosis, or be taking medication for this purpose. Furthermore, the patient must not be in a coma, exhibit a RASS score between -3 and +4, and have a GCS score of 10 or above.

You may qualify if:

• Over 18 years old
• Previous cardiovascular surgery
• No mental deficiency and visual and hearing impairment
• Participants' acceptance to participate in the research
• The patient is not in coma (RASS score between -3 and +4, GCS score of 10 and above)

You may not qualify if:

• Cardiovascular surgery under emergency conditions
• Being diagnosed with delirium, dementia, psychiatric illness and taking medication for this reason before the surgery
• Serious conditions such as cardiopulmonary resuscitation during surgery
• Alcohol and drug addiction
• Duration of mechanical ventilation exceeding 36 hours
• Dying in the intensive care unit within 24 hours

Sponsors & Collaborators

• Kubra Gunes: lead

Related Publications (2)

• Rudolph JL, Jones RN, Levkoff SE, Rockett C, Inouye SK, Sellke FW, Khuri SF, Lipsitz LA, Ramlawi B, Levitsky S, Marcantonio ER. Derivation and validation of a preoperative prediction rule for delirium after cardiac surgery. Circulation. 2009 Jan 20;119(2):229-36. doi: 10.1161/CIRCULATIONAHA.108.795260. Epub 2008 Dec 31.

  PMID: 19118253 BACKGROUND

• Xu Y, Meng Y, Qian X, Wu H, Liu Y, Ji P, Chen H. Prediction model for delirium in patients with cardiovascular surgery: development and validation. J Cardiothorac Surg. 2022 Oct 1;17(1):247. doi: 10.1186/s13019-022-02005-3.

  PMID: 36183105 BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Nursel Vatansever

  Uludag University

  STUDY DIRECTOR

Central Study Contacts

Kubra Gunes

CONTACT

05379406215; kubragunes213@gmail.com

Nursel Vatansever

CONTACT

nurselaydin@uludag.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: RN, MSc

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 12, 2024
• Study Start: December 15, 2024
• Primary Completion: December 15, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share