Actively Recruiting
Pressure Injuries in the Operating Room and Their Perioperative Incidence in Patients Undergoing Neurosurgery.
Led by Instituto de Investigación Marqués de Valdecilla · Updated on 2024-09-26
170
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the development of pressure injuries in adults undergoing neurosurgery lasting more than three hours. It is a descriptive, longitudinal, prospective observational study focusing on patients aged 18 and older scheduled for neurosurgery. The study aims to gather data on the incidence and risk factors of pressure injuries during the perioperative period, as these injuries are mostly preventable yet pose significant medical costs and risks. The study follows patients consecutively from the immediate preoperative phase through the surgery and up to 72 hours post-surgery. Data will be collected through direct observation and clinical record review during four phases: immediate preoperative, intraoperative, immediate postoperative, and late postoperative. The study records injury locations based on patient positioning and analyzes risk factors contributing to pressure injuries. Participants will be closely observed during surgery and for 72 hours afterward, with assessments including wound observations and data recorded on standardized sheets. The primary outcome is the incidence of pressure injuries measured within this timeframe. Secondary outcomes include injury locations and associated risk factors. The study runs from December 2023 to January 2025, with data analysis and results dissemination planned after completion.
CONDITIONS
Brief Title
Pressure Injuries in the Operating Room and Their Perioperative Incidence in Patients Undergoing Neurosurgery.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who understand and sign the informed consent.
- Adult patients aged 18 to 100 years of both sexes undergoing scheduled neurosurgery lasting more than 3 hours.
- Patients positioned in prone, supine, lateral, or beach chair/sitting positions.
- Surgeries requiring bladder catheterisation with body temperature measurement.
- Patients admitted to the neurosurgery ward the day before surgery.
You will not qualify if you...
- Patients who do not sign informed consent.
- Patients with visible pressure injuries present before surgery.
- Patients with cognitive disorders or difficulties in written and oral understanding.
- Patients who refuse the operation.
- Patients not operated due to lack of prior time.
- Patients not receiving vasoactive drugs such as ephedrine, phenylephrine, or noradrenaline.
- Patients whose postoperative period is in the ICU.
- Patients whose surgery lasts less than 3 hours despite initial estimates.
- Patients admitted more than 24 hours before surgery.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery duration plus immediate post-operative period
Participants undergo neurosurgery lasting more than 3 hours and are monitored during and immediately after surgery for pressure injuries.
1 surgery visit (in-person)
Duration - 72 hours after surgery
Participants are observed for pressure injuries through direct wound observation for 72 hours following surgery.
Approximately 3 follow-up visits within 72 hours
Trial Site Locations
Total: 2 locations
1
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Not Yet Recruiting
2
Hospital universitario marques de valdecilla
Santander, Spain, 39008
Actively Recruiting
Research Team
M
maria perez sastre
L
Lucía Lavin
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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