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

NCT06615271 | Recruiting

• 1 other identifier: UPS
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 2

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.

Conditions

PRESSURE INJURIES

Keywords

injuries; surgical; neurosurgery; prevention; nurse; clinical practice

Outcome Measures

Primary Outcomes (1)

• Incidence of pressure injuries in the neurosurgery, in surgical interventions lasting more than 3 hours. It will be measured by direct observation of the wound, from the time the patient enters the operating room until the next 72 hours thereafter.

  72 hours

Secondary Outcomes (2)

• Locations of the pressure injuries concerning to the different types of positioning.It will be measured by direct observation of the wound, from the time the patient enters the operating room until the next 72 hours thereafter.

  72 hours

• the risk factors that contribute to the appearance of pressure injurieS. It will be measured by direct observation of the wound, from the time the patient enters the operating room until the next 72 hours thereafter.

  72 hours

Study Arms (1)

Patients who have undergone neurosurgery form more than 3 hours.

The ones who perform the selection criteria determined for this study will be chosen consecutively, and a follow-up will be carried out from the immediate preoperative moment until 72 hours once the surgery has finished.

Procedure: Neurosurgery

Interventions

Neurosurgery PROCEDURE

Patients who have undergone neurosurgery form more than 3 hours.

Patients who have undergone neurosurgery form more than 3 hours.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients over 18 years, women and men.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Marqués de Valdecilla: lead

Study Sites (2)

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

NOT YET RECRUITING

Hospital universitario marques de valdecilla

Santander, 39008, Spain

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer; Wounds and Injuries

Interventions

Neurosurgical Procedures

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

maria perez sastre

CONTACT

+34942203389; mariaperezsastre95@gmail.com

Lucía Lavin

CONTACT

+34942203389; eclinicos5@idival.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: September 26, 2024
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)