Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06685263

Development of Perioperative Delirium Prediction Model

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Development of a delirium risk prediction model

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kubra Gunes

CONTACT

[email protected]

05379406215

Nursel Vatansever

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Kubra Gunes

Other

Registry information

Official study title

Development of a Perioperative Delirium Prediction Model in Patients Undergoing Cardiovascular Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.