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Development of Perioperative Delirium Prediction Model

K

Kubra Gunes

Status

Not yet enrolling

Conditions

Cardiovascular Surgery

Treatments

Behavioral: Group 2
Behavioral: Group 1

Study type

Observational

Funder types

Other

Identifiers

NCT06685263
2024-15/3

Details and patient eligibility

About

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.

Full 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.

Enrollment

770 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

770 participants in 2 patient groups

Development group
Description:
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.
Treatment:
Behavioral: Group 1
Validation group
Description:
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.
Treatment:
Behavioral: Group 2

Trial contacts and locations

0

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Central trial contact

Kubra Gunes; Nursel Vatansever

Data sourced from clinicaltrials.gov

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