Development of Perioperative Delirium Prediction Model

NCT ID: NCT06685263

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 770 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2026-05-30

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.

Detailed Description

Postoperative delirium is associated with an increased incidence of postoperative complications, which in turn lead to cognitive dysfunction, increased mortality, and the need for long-term care. It is predicted in the literature that the early detection of delirium cases, of which 30% are known to be preventable, improves prognosis. Accordingly, a prediction model based on the identification of delirium risk factors can categorise intensive care patients into distinct risk levels according to their probability of developing delirium, thus enabling healthcare professionals to ascertain the likelihood of delirium and implement suitable preventive measures. A review of the literature reveals the existence of numerous delirium prediction models designed to identify patients at high risk of developing delirium. However, there is a paucity of studies examining models for predicting delirium risk in the context of cardiovascular surgery. The objective of this study is to develop a delirium risk prediction model for the perioperative period in patients undergoing cardiovascular surgery.

Conditions

Cardiovascular Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Group 1

Intervention Type: 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.

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.

Group 2

Intervention Type: 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.

Interventions

Group 1

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.

Intervention Type: BEHAVIORAL

Group 2

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kubra Gunes

OTHER

Sponsor Role: lead

Responsible Party

Kubra Gunes

RN, MSc

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nursel Vatansever

Role: STUDY_DIRECTOR

Uludag University

Central Contacts

Kubra Gunes

Role: CONTACT

kubragunes213@gmail.com

05379406215

Nursel Vatansever

Role: CONTACT

nurselaydin@uludag.edu.tr

References

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.

Reference Type: BACKGROUND

PMID: 19118253 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36183105 (View on PubMed)

Other Identifiers

2024-15/3

Identifier Type: -

Identifier Source: org_study_id