Observing pressure injuries in neurosurgery patients during surgery
Pressure Injuries in the Operating Room and Their Perioperative Incidence in Patients Undergoing Neurosurgery.
This study looks at how often pressure injuries happen in adults during long neurosurgeries to help create better prevention guidelines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Instituto de Investigación Marqués de Valdecilla Academic / other |
| Locations | 2 sites (Santander, Cantabria and 1 other locations) |
| Trial ID | NCT06615271 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence of pressure injuries in patients undergoing neurosurgery at the HUMV operating rooms. It will follow adult patients scheduled for surgeries lasting over three hours, collecting data from the preoperative phase through to 72 hours post-surgery. The study will utilize direct observation and clinical record immersion to gather information across four phases: preoperative, intraoperative, immediate postoperative, and late postoperative. The goal is to calculate the cumulative incidence of pressure injuries and develop updated clinical care guidelines for prevention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for neurosurgery lasting more than three hours.
Not a fit: Patients with existing pressure injuries or cognitive disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention protocols for pressure injuries in surgical patients, enhancing patient safety and outcomes.
How similar studies have performed: Previous studies have indicated that pressure injuries in surgical settings are largely preventable, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who understand and sign the informed consent. * Adult patients of both sexes who will undergo a schedule surgery of more than 3 hours, by the service of neurosurgery of the University Hospital Marqués of Valdecilla (HUMV), between 2023 and 2024. * Patients positioned in prone, supine, lateral and beach chair/sitting. * Surgeries susceptible to bladder catheterisation with body temperature measurement. * Patients admitted into neurosurgery ward, the day before surgery. Exclusion Criteria: * Patients who do not sign informed consent. * Patients with visible pressure injurie present before surgery. * Patients with cognitive disorder or written and oral knowledge difficulty. * Patients who reject the operation. * Patients not operated due to lack of prior time. * Patients who do not receive vasoactive drugs such as ephedrine, phenylephrine and noradrenaline. * Patients whose postoperative period is performed in the ICU. * Patients whose surgical intervention, despite the initial estimate of the surgical time, lasted less than 3 hours. * Patients admitted \>24 hours prior the surgery.
Where this trial is running
Santander, Cantabria and 1 other locations
- Hospital Universitario Marques de Valdecilla — Santander, Cantabria, Spain (Not_yet_recruiting)
- Hospital universitario marques de valdecilla — Santander, Spain (Recruiting)
Study contacts
- Study coordinator: maria perez sastre
- Email: mariaperezsastre95@gmail.com
- Phone: +34942203389
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.