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

Delirium Clinical Trial

— VisualMaterial  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05932394
• Other study ID #: CEIm 2155
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 26, 2023

Study information

• Verified date: June 2023
• Source: University of Huelva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 26, 2023
• Est. primary completion date: June 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery
• Delirium
• Emergence Delirium
• Postoperative Delirium

Intervention

Behavioral:
• Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery
Patients are randomized into two groups (control group and intervention group). Initially, all patients are administered the "Mini-Mental State Examination scale" (MMSE) to assess their initial cognitive state and their sociodemographic and anthropometric data. In the intervention group, patients and/or companions are asked to provide visual material, which could consist of photographs of loved ones and/or places known to the patient. 30 minutes after the extubation of the patients, the CAM-ICU scale is administered. In the control group, after the surgical intervention and 30 minutes after the patient's extubation the CAM-ICU scale is administered.
• the usual unit treatment
CAM-ICU scale is administered to the Control group. No visual material is used.

Locations

Country	Name	City	State
Spain	University Hospital of Leon	Leon	Castilla-Leon

Sponsors (1)

Lead Sponsor	Collaborator
University of Huelva

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale	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.	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.
Primary	Mini-Mental State Examination (MMSE) scale	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.	Baseline (Beginning of the experiment)