Pressure Injuries in the Operating Room and Their Perioperative Incidence in Patients Undergoing Neurosurgery.

Last updated: September 24, 2024
Sponsor: Instituto de Investigación Marqués de Valdecilla
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pressure Ulcer

Treatment

Neurosurgery

Clinical Study ID

NCT06615271
UPS
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who understand and sign the informed consent.

  • Adult patients of both sexes who will undergo a schedule surgery of more than 3hours, by the service of neurosurgery of the University Hospital Marqués ofValdecilla (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

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 andnoradrenaline.

  • Patients whose postoperative period is performed in the ICU.

  • Patients whose surgical intervention, despite the initial estimate of the surgicaltime, lasted less than 3 hours.

  • Patients admitted >24 hours prior the surgery.

Study Design

Total Participants: 170
Treatment Group(s): 1
Primary Treatment: Neurosurgery
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
January 01, 2025

Study 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.

Connect with a study center

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital universitario marques de valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

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