Delirium Clinical Trial
— VisualMaterialOfficial title:
Projection of Visual Material on Postoperative Delirium in Patients Undergoing Cardiac Surgery
NCT number | NCT05932394 |
Other study ID # | CEIm 2155 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | June 26, 2023 |
Verified date | June 2023 |
Source | University of Huelva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | University Hospital of Leon | Leon | Castilla-Leon |
Lead Sponsor | Collaborator |
---|---|
University of Huelva |
Spain,
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04551508 -
Delirium Screening 3 Methods Study
|
||
Recruiting |
NCT05891873 -
Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
|
||
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Recruiting |
NCT06194474 -
Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
|
||
Completed |
NCT03095417 -
Improving the Recovery and Outcome Every Day After the ICU
|
N/A | |
Completed |
NCT05395559 -
Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
|
||
Terminated |
NCT03337282 -
Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
|
||
Not yet recruiting |
NCT04846023 -
Pediatric Delirium Screening in the PICU Via EEG
|
N/A | |
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
Withdrawn |
NCT02673450 -
PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.
|
||
Recruiting |
NCT03256500 -
Transcranial Direct Current Stimulation for the Treatment of Delirium
|
N/A | |
Completed |
NCT02890927 -
Geriatric-CO-mAnagement for Cardiology Patients in the Hospital
|
N/A | |
Not yet recruiting |
NCT02892968 -
ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients
|
N/A | |
Recruiting |
NCT03165539 -
Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
|
||
Completed |
NCT02518646 -
DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models
|
N/A | |
Completed |
NCT02554253 -
The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
|
Phase 2 | |
Recruiting |
NCT02305589 -
The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium
|
N/A | |
Completed |
NCT02628925 -
Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale
|
N/A |