Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery

Not Applicable

Completed

• Conditions: Delirium; Postoperative Delirium; Cardiac Surgery

• Registration Number: NCT05932394
• Lead Sponsor: University of Huelva

Brief Summary

The aim is to evaluate the impact of visual projection of images of relatives or loved ones in patients undergoing cardiac surgery in the immediate postoperative period, and its influence on the incidence and development of postoperative delirium.

A randomized, double-blind clinical trial was designed in the immediate postoperative period of adult patients undergoing cardiac surgery. CONSORT guidelines were followed.

A control group and an intervention group were established. In the intervention group, the patients underwent a visual projection, while the usual unit treatment was carried out with the control group. Sociodemographic, anthropometric, anesthetic, and surgical variables were also recorded. The postoperative delirium assessment scale used was the "Confusion Assessment Method for the Intensive Care Unit scale" (CAM-ICU).

The projection of visual material could reduce the incidence of postoperative delirium in patients undergoing cardiac surgery, although it cannot be established that it is effective as a treatment once the pathology is already established.

The results obtained suggest that the visual projection of images is an effective and economical tool to address an increasingly incidental problem due to the aging of the population.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2023-06
• Primary Completion: 2023-06-26
• Study Completion: 2023-06-26
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-06-30
• Last Update Submitted: 2023-06-30
• Study First Posted: 2023-07-06
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Patients undergoing heart surgery (aortic valve replacement, mitral valve replacement and/or coronary bypass) in the immediate postoperative period during their stay in the cardiac resuscitation unit.
• Over 18 years of age

Exclusion Criteria

• Not being sedated for at least 24 hours.
• Leven of consciousness.
• Spanish speaker.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale	2 times, previous and post intervention, in the first 24 hours after cardiac surgery. This method is applied individually, through study completion, in an average of 1 year.	Changes in the scale for the diagnosis of delirium in critical care units were assessed previous and post intervention of visual material projection.; The final CAM-ICU-7 score ranges from 0-7 with 7 being most severe. CAM-ICU-7 scores were further categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.
Mini-Mental State Examination (MMSE) scale	Baseline (Beginning of the experiment)	Initially, regardless of the group to which they belonged, all patients were administered the MMSE scale to assess their initial cognitive state and their sociodemographic and anthropometric data were collected.; The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.

Trial Locations

Locations (1)

University Hospital of Leon; 🇪🇸 Leon, Castilla-Leon, Spain