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| Name | Class |
|---|---|
| Hospital de San Jose | OTHER |
| Comisión Nacional de Investigación CientÃfica y Tecnológica | OTHER_GOV |
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In the world, 230 million surgeries are performed every year and US data indicates that more than a third of patients who undergo surgery are older than 65 years, in which between 10 and 70% develop postoperative delirium (POD). Patients who develop POD have poor outcomes, such as a longer hospital stay, a deterioration in functional and cognitive status, high mortality rates, and an increase in health costs.
Delirium is an entity that in a significant percentage is preventable, thus preventing the development of POD is fundamental. In fact, in older adults hospitalized in the no surgical ward, the implementation of non-pharmacological prevention measures of delirium has consistently shown to significantly prevent the development of this condition. However, limited information is available about the usefulness of non-pharmacological intervention protocols applied in the perioperative context to prevent POD.
The main aim of this project is to determine whether the application of non-pharmacological measures during the perioperative period prevents POD in elderly patients undergoing highly complex elective surgeries.
The hypothesis is that the application of these measures decreases the incidence of delirium in this population.
To determine whether non-pharmacological measures decrease the incidence of POD during the perioperative period in elderly patients undergoing highly complex elective surgeries, it will be performed a randomized clinical trial, where two groups of patients older than 75 years undergoing highly complex elective surgeries will be compared:
This study will be carried out in the surgical units of the Hospital Clinico de la Universidad de Chile (HCUCH) and in the Hospital San Jose (HSJ).
The expected result is to demonstrate that the interventions carried out by occupational therapists decrease the incidence of DPO in a significant way in comparison with standard prevention intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Standard non-pharmacological intervention during 5 days after surgery. |
|
| Treatment | Experimental | Occupational therapy intervention twice a day plus standard non-pharmacological prevention intervention during 5 days after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occupational therapy intervention | Behavioral | Prevention of postoperative delirium by occupational therapy intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delirium | Developing postoperative delirium evaluated by CAM (complete criteria for delirium diagnostic) | 5 days |
| Subsyndromal delirium | Developing postoperative subsyndromal delirium evaluated by CAM (incomplete criteria for delium diagnostic) | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lenght of hospital stay | Number of days between admission and discharge to the hospital | 30 days |
| Mortality | Percentage of patients who die between the day of surgery and 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonello Penna, MD/PhD | University of Chile | Principal Investigator |
| Evelyn Alvarez, TO/MSc | Universidad Central/Universidad de Chile | Principal Investigator |
| Constanza Briceño, TO/MSc | University of Chile | Principal Investigator |
| Eduardo Tobar, MD | University of Chile | Principal Investigator |
| Felipe Salech, MD/PhD | University of Chile | Principal Investigator |
| Daniela Ponce, Ing | University of Chile | Principal Investigator |
| Veronica Rojas, Nurse/MSc | University of Chile | Principal Investigator |
| Gonzalo Navarrete, MD | University of Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Investigación CÃnica Avanzada (CICA), Hospital Clinico de la Universidad de Chile | Santiago | RM | 7690306 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27660922 | Result | Alvarez EA, Garrido MA, Tobar EA, Prieto SA, Vergara SO, Briceno CD, Gonzalez FJ. Occupational therapy for delirium management in elderly patients without mechanical ventilation in an intensive care unit: A pilot randomized clinical trial. J Crit Care. 2017 Feb;37:85-90. doi: 10.1016/j.jcrc.2016.09.002. Epub 2016 Sep 10. | |
| 36817762 |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Elderly patients who will undergo major surgery will be randomized to 2 prevention groups of postoperative delirium:
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Patients were randomized in 16 blocks of 10 patients and only one investigator has the randomized information. This researcher will not have any role in the recruitment, intervention, and diagnosis of postoperative delirium. Also, the analysis of data will be performed by researchers who will be masked to the randomization information.
| Standard non-pharmacological prevention intervention | Behavioral | Prevention of postoperative delirium using standard non-pharmacological prevention measures |
|
| 30 days |
| Severity of delirium | Severity of delirium will be evaluated with questionnaire CAM-S | 5 days |
| Duration of delirium | Number of days in which the patients have delirium | 5 days |
| Alvarez EA, Rojas VA, Caipo LI, Galaz MM, Ponce DP, Gutierrez RG, Salech F, Tobar E, Reyes FI, Vergara RC, Egana JI, Briceno CA, Penna A. Non-pharmacological prevention of postoperative delirium by occupational therapy teams: A randomized clinical trial. Front Med (Lausanne). 2023 Feb 2;10:1099594. doi: 10.3389/fmed.2023.1099594. eCollection 2023. |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |