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Starting soon Not applicable

Effect of Positioning Protocol on Skin Pressure Injury and Shoulder Traction Pain in Neurosurgical Patients

NCT07791056 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-08-27

Condition(s) studied

Pressure Injuries

Investigational drug(s) / intervention(s)

Modified Lateral Decubitus Positioning ProtocolConventional Lateral Decubitus Positioning

Modified Lateral Decubitus Positioning Protocol: Patients receive a modified lateral decubitus positioning protocol utilizing an L-shaped one-piece arm board for dependent arm suspension and a funnel-shaped adhesive film for shoulder fixation at a 45-degree angle. This approach aims to optimize pressure redistribution and reduce nerve traction during neurosurgical procedures under general anesthesia. Positioning is performed after induction of anesthesia and before surgical incision.

Conventional Lateral Decubitus Positioning: Patients receive the standard traditional lateral decubitus positioning method routinely used in clinical practice, including axillary rolls, manual shoulder taping, and sequential placement of support pads. No specialized arm board or adhesive fixation is used.

Study summary

This study evaluates a modified lateral decubitus positioning method designed to prevent pressure injuries and reduce shoulder traction pain in patients undergoing neurosurgical procedures under general anesthesia. Participants will be randomly assigned to either the modified positioning group or the conventional positioning group. The main goal is to compare the incidence of Stage I pressure injuries (per NPUAP criteria) at the end of surgery and the severity of shoulder pain (measured by VAS) at 24 hours postoperatively. Secondary outcomes include positioning time, healthcare worker satisfaction, and changes in CORN intraoperative pressure injury risk scores. This research aims to provide evidence-based guidance for optimizing intraoperative nursing care and improving patient safety and comfort in the operating room.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * Elective neurosurgical procedure under general anesthesia * Planned surgical position: lateral decubitus * Expected operative duration ≥ 2 hours (from completion of positioning to end of surgery) Exclusion Criteria: * Pre-existing skin injury before surgery * Acute or chronic skin disease * Communication disorder / inability to express pain verbally * Severe cardiac, hepatic, or renal disease Withdrawal Criteria: * Intraoperative change of surgical position from lateral decubitus to another position due to unexpected surgical requirements * Intraoperative hemodynamic instability or other critical events requiring immediate repositioning or termination of the procedure * Inability to complete the 24-hour postoperative follow-up assessment (e.g., transfer to ICU, unplanned reoperation, or death) * Development of a serious adverse event directly attributable to the positioning procedure that necessitates discontinuation of the assigned protocol

Primary outcome measure(s)

  • Incidence of skin redness (blanching erythema) at end of surgery — At end of operation
    Number (%) of participants with pressure-induced skin redness (defined as blanching on 3-second fingertip pressure) at dependent sites (sacrum, ASIS, external malleolus, axilla, rib margin, lateral knee) assessed by trained researcher at operative end.

Trial sites (1)

FacilityCityRegionStatus
General hospital of Ningxia medical university Yinchuan Ningxia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07791056 on ClinicalTrials.gov ↗ ← All trials in China