Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615271
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-10-24
Brief Title:
Pressure Injuries in the Operating Room and Their Perioperative Incidence in Patients Undergoing Neurosurgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pressure Injuries in the Operating Room and Their Perioperative Incidence in Patients Undergoing Neurosurgery
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UPS
Brief Summary:
This research project is a descriptive longitudinal prospective observational study in the HUMV neurosurgery operating rooms The patients included will be adults 18 years old or older who will be scheduled for surgery by the Neurosurgery service Those who meet the selection criteria determined for this study will be chosen consecutively and will be followed from the immediate preoperative moment until 72 hours after the end of the surgery Data collection shall be carried out by direct observation and immersion in clinical records of patients who have signed the informed consent The study will be carried out in 4 phases immediate preoperative intraoperative immediate postoperative and late postoperative recording the data using various measuring instruments and a record sheet Finally the cumulative incidence of LPPs developed in the perioperative environment will be calculated and a statistical analysis will be performed
Detailed Description:
The surgical area represents a scenario to be taken into account in the prevention of pressure injuries LPP being an essential and priority aspect in these injuries demonstrating that more than 95 of them are avoidable The latest national incidence study conducted in 2019 shows an incidence figure of 14 in post-surgical units and resuscitation approaching the US between 12 and 66 of incidence in surgical patients being considered a sentinel event considering a medical cost of more than 268 billion
The project will be developed from June 2023 to May 2025 It has been approved by the Research Ethics Committee of Cantabria and the start of the study is scheduled for October 2023 Afterwards the analysis of the data and the interpretation of the results will be done ending with a final article to be disseminated and disseminated in magazines congresses or national and international talks
Surgical patients present specific risk factors leading to the appearance of LPP Therefore this study aims to obtain some initial data to create a clinical care guide and prevention protocols updated and specific for clinical practice
The project will be developed from June 2023 to May 2025 It has been approved by the Research Ethics Committee of Cantabria and the start of the study is scheduled for October 2023 Afterwards the analysis of the data and the interpretation of the results will be done ending with a final article to be disseminated and disseminated in magazines congresses or national and international talks
Surgical patients present specific risk factors leading to the appearance of LPP Therefore this study aims to obtain some initial data to create a clinical care guide and prevention protocols updated and specific for clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None