Pressure Injuries
Conditions
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.
Detailed description
This is a randomized, single-blind, parallel-group controlled trial conducted at the Department of Anesthesiology and Perioperative Medicine, General Hospital of Ningxia Medical University. The study aims to evaluate the efficacy of a modified lateral decubitus positioning protocol in reducing intraoperative pressure injuries and postoperative shoulder traction pain among patients undergoing elective neurosurgical procedures under general anesthesia. Study Design and Masking: Patients are randomly assigned to either the experimental group (modified positioning protocol) or the control group (conventional positioning protocol). Participants are blinded to their group allocation, as all positioning procedures are performed after the induction of general anesthesia and before surgical incision. However, due to the nature of the procedural intervention, operating room staff (care providers) and outcome assessors cannot be blinded to the group allocation. Interventions: Experimental Group: Patients receive a modified 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. Control Group: Patients receive the standard traditional lateral decubitus positioning method routinely used in clinical practice, involving axillary rolls, manual shoulder taping, and sequential placement of support pads. Procedures and Assessments: Upon obtaining informed consent, baseline data including the CORN (Chinese Operating Room Nurse) intraoperative pressure injury risk score are collected. During the procedure, positioning time is recorded from the command to turn the patient to the circulating nurse's final confirmation. Postoperatively, the incidence of skin erythema and Stage I pressure injuries (assessed via NPUAP criteria) is documented. Shoulder traction pain is evaluated at 24 hours postoperatively using the Visual Analog Scale (VAS). Additionally, satisfaction levels regarding the positioning method are surveyed among surgeons, anesthesiologists, and circulating nurses. Objective: This study seeks to establish an evidence-based, ergonomic positioning standard that enhances patient safety and comfort while improving workflow efficiency for the surgical team.
Interventions
PROCEDUREModified 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.
PROCEDUREConventional 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.
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Stage I pressure injury (NPUAP) at end of surgery | At end of operation | Number (%) per NPUAP staging |
| Shoulder traction pain VAS at 24 h postop | 24 hours after surgery | Visual analogue scale(VAS) 0-10 (0 none, 1-3 mild, 4-6 moderate, 7-10 severe); reported as median (Q1, Q3) |
| Positioning time (minutes) | Intraoperative, single time point | From command "turn" to circulating nurse sign-off; mean ± SD |
| Healthcare worker satisfaction with positioning method | Immediately after positioning | 3-level scale (very satisfied / satisfied / unsatisfied) for surgeons, anesthesiologists, circulating nurses; reported as count (%) |
| CORN Intraoperative Acquired Pressure Injury Risk Score (Preoperative Assessment) | On enrollment, immediately before anesthesia induction (preoperative) | Assessed using the Chinese Operating Room Nurse (CORN) intraoperative acquired pressure injury risk scale (preoperative dimension, 6 items: ASA class, BMI, skin status, limb mobility, planned operative duration, diabetes). Range 6-24; higher score indicates higher risk. Evaluated once at enrollment. |
| CORN Intraoperative Acquired Pressure Injury Risk Score (Intraoperative Dynamic Assessment) | At end of surgery, before transfer out of operating room (intraoperative) | Assessed using the CORN scale intraoperative dimension (4 items: body temperature loss factor, blood loss volume, pressure/shear change, actual operative duration). Range 4-16; higher score indicates higher risk. Evaluated once at end of surgery before leaving operating room. |
Countries
China
Contacts
CONTACTLiwei Huang
Outcome results
None listed