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

June 30, 2023 updated by: Juan Gómez-Salgado, University of Huelva

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Castilla-Leon
      • Leon, Castilla-Leon, Spain, 24008
        • University Hospital of León

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control group
In the control group, after the surgical intervention and 30 minutes after the patient's extubation the CAM-ICU scale is administered, recording its value as R0. The following day, at 9:00 a.m., another nurse uses the CAM-ICU scale, noting its value as R1. If postoperative delirium was detected during the day and night, the unit's usual treatment was followed: administration of haloperidol and/or dexmedetomidine.
Behavioral: the usual unit treatment
CAM-ICU scale is administered to the Control group. No visual material is used.
Active Comparator: Intervention group
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, recording its value as R0. At night, the projection of images provided by the patient are replaced by a nocturnal visual projection (night sky with stars and moon), ensuring that the patient is able to identify that it was nighttime. Finally, at 9:00 a.m., a nurse who had not worked at night and therefore did not know which patients had received the intervention, administers the CAM-ICU scale again, recording its value as R1.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale
Time Frame: 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.
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.
Mini-Mental State Examination (MMSE) scale
Time Frame: 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.
Baseline (Beginning of the experiment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Huelva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

June 26, 2023

Study Completion (Actual)

June 26, 2023

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIm 2155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data available under reasonable request to the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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