Trials / Recruiting
RecruitingNCT06615271
Pressure Injuries in the Operating Room and Their Perioperative Incidence in Patients Undergoing Neurosurgery.
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 170 (estimated)
- Sponsor
- Instituto de Investigación Marqués de Valdecilla · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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 $26.8 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Neurosurgery | Patients who have undergone neurosurgery form more than 3 hours. |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2024-12-01
- Completion
- 2025-01-01
- First posted
- 2024-09-26
- Last updated
- 2024-09-26
Locations
2 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT06615271. Inclusion in this directory is not an endorsement.