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

NCT07791056 | Not Yet Recruiting DMC

• 1 other identifier: HLW01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Injuries

Outcome Measures

Primary Outcomes (1)

• Incidence of skin redness (blanching erythema) at end of surgery

  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.

  At end of operation

Secondary Outcomes (6)

• Incidence of Stage I pressure injury (NPUAP) at end of surgery

  At end of operation

• Shoulder traction pain VAS at 24 h postop

  24 hours after surgery

• Positioning time (minutes)

  Intraoperative, single time point

• Healthcare worker satisfaction with positioning method

  Immediately after positioning

• CORN Intraoperative Acquired Pressure Injury Risk Score (Preoperative Assessment)

  On enrollment, immediately before anesthesia induction (preoperative)

Study Arms (2)

Modified Positioning Protocol (Group M)

EXPERIMENTAL

After anesthetic induction, patient transferred from stretcher to OR table; 90° roll; dependent acromion aligned with headboard; dependent arm suspended on L-shaped one-piece arm board; operative-side arm hangs naturally; funnel-shaped medical adhesive film replaces shoulder tape, pulled 45° toward foot along sagittal plane, covering deltoid/pectoralis/trapezius; dependent leg extended, upper leg flexed on molded fluid pad; pelvic rest at pubic symphysis and sacrum; head fixed after headboard removed. Fluid pad pre-molded before induction.

Procedure: Modified Lateral Decubitus Positioning Protocol

Traditional Positioning Protocol (Group T)

OTHER

Axillary roll, iliac crest roll, leg pad placed sequentially; dependent arm extended on table-side hand board, upper arm flexed to chest; running posture for legs; pelvic frame fixed; shoulder taped with cotton band and pulled distally; knee restrained with strap.

Procedure: Conventional Lateral Decubitus Positioning

Interventions

Modified Lateral Decubitus Positioning Protocol PROCEDURE

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.

Modified Positioning Protocol (Group M)

Conventional Lateral Decubitus Positioning PROCEDURE

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.

Traditional Positioning Protocol (Group T)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General hospital of Ningxia medical university

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Liwei Huang

CONTACT

86-951-674-5913; huangliwei520@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-blind, parallel-group, randomized controlled trial. Due to the nature of the procedural intervention, care providers and outcome assessors cannot be blinded to the group allocation. However, participants are blinded, as all positioning procedures are performed after the induction of general anesthesia and before the surgical incision, ensuring that patients have no awareness of whether they received the modified or conventional positioning protocol.

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)