Clinical trial NCT06685263: Development of Perioperative Delirium Prediction Model
Official title: Development of a Perioperative Delirium Prediction Model in Patients Undergoing Cardiovascular Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiovascular Surgery
Keywords: cardiovascular surgery
delirium
prediction model
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Development of a delirium risk prediction model
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uludag University
name: Nursel Vatansever
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.