Pressure InjuriesNCT07791056
Effect of Positioning Protocol on Skin Pressure Injury and Shoulder Traction Pain in Neurosurgical Patients
A study testing Modified Lateral Decubitus Positioning Protocol and Conventional Lateral Decubitus Positioning in people with Pressure Injuries, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injuries
- What is being tested?
- Modified Lateral Decubitus Positioning Protocol and Conventional Lateral Decubitus Positioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
General hospital of Ningxia medical university
Yinchuan, Ningxia, 750004
Liwei Huang, 86-951-674-5913, huangliwei520@126.com
About this study
Official title: Effect of Modified Lateral Decubitus Positioning Protocol on Skin Pressure Injury and Shoulder Traction Pain in Neurosurgical Patients
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.
Read the 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.
- Conditions
- Pressure Injuries
- Being tested
- Modified Lateral Decubitus Positioning Protocol, Conventional Lateral Decubitus Positioning
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Lateral Decubitus Positioning ProtocolProcedure or surgery
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 PositioningProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Lateral Decubitus Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At end of operation
Secondary outcomes (6)
Incidence of Stage I pressure injury (NPUAP) at end of surgery
Number (%) per NPUAP staging
Measured: At end of operation
Shoulder traction pain VAS at 24 h postop
Visual analogue scale(VAS) 0-10 (0 none, 1-3 mild, 4-6 moderate, 7-10 severe); reported as median (Q1, Q3)
Measured: 24 hours after surgery
Positioning time (minutes)
From command "turn" to circulating nurse sign-off; mean ± SD
Measured: Intraoperative, single time point
Healthcare worker satisfaction with positioning method
3-level scale (very satisfied / satisfied / unsatisfied) for surgeons, anesthesiologists, circulating nurses; reported as count (%)
Measured: Immediately after positioning
CORN Intraoperative Acquired Pressure Injury Risk Score (Preoperative Assessment)
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.
Measured: On enrollment, immediately before anesthesia induction (preoperative)
CORN Intraoperative Acquired Pressure Injury Risk Score (Intraoperative Dynamic Assessment)
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.
Measured: At end of surgery, before transfer out of operating room (intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791056
- Sponsor's protocol ID
- HLW01
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modified Lateral Decubitus Positioning Protocol on Skin Pressure Injury and Shoulder Traction Pain in Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT07791056
- Acronym / sponsor ID
- HLW01
- Conditions
- Pressure Injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Modified Positioning Protocol (Group M) | Experimental | Procedure: Modified Lateral Decubitus Positioning ProtocolAfter 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. |
| Traditional Positioning Protocol (Group T) | Other | Procedure: Conventional Lateral Decubitus PositioningAxillary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- Pre-existing skin injury before surgery
- Acute or chronic skin disease
- Communication disorder / inability to express pain verbally
- Severe cardiac, hepatic, or renal disease
- Intraoperative change of surgical position from lateral decubitus to another position due to unexpected surgical requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Lateral Decubitus Positioning ProtocolPatients 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. | Procedure or surgery | Modified Positioning Protocol (Group M) |
| Conventional Lateral Decubitus PositioningPatients 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. | Procedure or surgery | Traditional Positioning Protocol (Group T) |
Primary outcome
Incidence of skin redness (blanching erythema) at end of surgery
Time frame: 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.
6 secondary outcomes
Incidence of Stage I pressure injury (NPUAP) at end of surgery
Time frame: At end of operation
Shoulder traction pain VAS at 24 h postop
Time frame: 24 hours after surgery
Positioning time (minutes)
Time frame: Intraoperative, single time point
Healthcare worker satisfaction with positioning method
Time frame: Immediately after positioning
CORN Intraoperative Acquired Pressure Injury Risk Score (Preoperative Assessment)
Time frame: On enrollment, immediately before anesthesia induction (preoperative)
CORN Intraoperative Acquired Pressure Injury Risk Score (Intraoperative Dynamic Assessment)
Time frame: At end of surgery, before transfer out of operating room (intraoperative)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Pressure Injuries
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Lateral Decubitus Positioning Protocol and Conventional Lateral Decubitus Positioning in people with Pressure Injuries, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liwei Huang (86-951-674-5913, huangliwei520@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of skin redness (blanching erythema) at end of surgery (time frame: At end of operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.