Effect of Positioning Protocol on Skin Pressure Injury and Shoulder Traction Pain in Neurosurgical Patients
Effect of Modified Lateral Decubitus Positioning Protocol on Skin Pressure Injury and Shoulder Traction Pain in Neurosurgical Patients
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Liwei Huang
- Telefonnummer: 86-951-674-5913
- E-post: huangliwei520@126.com
Studiesteder
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Ningxia
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Yinchuan, Ningxia, Kina, 750004
- General Hospital of Ningxia Medical University
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Ta kontakt med:
- Liwei Huang
- Telefonnummer: 86-951-674-5913
- E-post: huangliwei520@126.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Modified Positioning Protocol (Group M)
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.
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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.
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Annen: Traditional Positioning Protocol (Group T)
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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of skin redness (blanching erythema) at end of surgery
Tidsramme: At end of operation
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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.
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At end of operation
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Stage I pressure injury (NPUAP) at end of surgery
Tidsramme: At end of operation
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Number (%) per NPUAP staging
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At end of operation
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Shoulder traction pain VAS at 24 h postop
Tidsramme: 24 hours after surgery
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Visual analogue scale(VAS) 0-10 (0 none, 1-3 mild, 4-6 moderate, 7-10 severe); reported as median (Q1, Q3)
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24 hours after surgery
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Positioning time (minutes)
Tidsramme: Intraoperative, single time point
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From command "turn" to circulating nurse sign-off; mean ± SD
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Intraoperative, single time point
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Healthcare worker satisfaction with positioning method
Tidsramme: Immediately after positioning
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3-level scale (very satisfied / satisfied / unsatisfied) for surgeons, anesthesiologists, circulating nurses; reported as count (%)
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Immediately after positioning
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CORN Intraoperative Acquired Pressure Injury Risk Score (Preoperative Assessment)
Tidsramme: On enrollment, immediately before anesthesia induction (preoperative)
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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.
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On enrollment, immediately before anesthesia induction (preoperative)
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CORN Intraoperative Acquired Pressure Injury Risk Score (Intraoperative Dynamic Assessment)
Tidsramme: At end of surgery, before transfer out of operating room (intraoperative)
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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.
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At end of surgery, before transfer out of operating room (intraoperative)
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
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Andre studie-ID-numre
- HLW01
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