Development of Perioperative Delirium Prediction Model

ConditionCardiovascular Surgery

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorKubra Gunes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Over 18 years old

Previous cardiovascular surgery

No mental deficiency and visual and hearing impairment

Participants' acceptance to participate in the research

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

770 Participants

are divided into 2 treatment groups

Group A: Development group1 intervention

Group B: Validation group1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

1 year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kubra Gunes

Lead sponsor

Uludag University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: