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

NCT ID: NCT05932394

Last Updated: 2023-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-06-26

Brief Summary

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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

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Conditions

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Delirium Postoperative Delirium Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

the usual unit treatment

Intervention Type BEHAVIORAL

CAM-ICU scale is administered to the Control group. No visual material is used.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

the usual unit treatment

CAM-ICU scale is administered to the Control group. No visual material is used.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Huelva

OTHER

Sponsor Role lead

Responsible Party

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Juan Gómez-Salgado

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Leon

León, Castille and León, Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CEIm 2155

Identifier Type: -

Identifier Source: org_study_id

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