UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053254 |
|---|---|
| Receipt number | R000060774 |
| Scientific Title | Prevention of postoperative skin disorders and pressure injuries in the neurosurgical park bench position surgery: a prospective cohort study |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2024/01/01 01:37:35 |
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Basic information
Public title
Prevention of postoperative skin disorders and pressure injuries in the neurosurgical park bench position surgery: a prospective cohort study
Acronym
Prevention of postoperative skin disorders and pressure injuries in the neurosurgical park bench position surgery: a prospective cohort study
Scientific Title
Prevention of postoperative skin disorders and pressure injuries in the neurosurgical park bench position surgery: a prospective cohort study
Scientific Title:Acronym
Prevention of postoperative skin disorders and pressure injuries in the neurosurgical park bench position surgery: a prospective cohort study
Region
| Japan |
Condition
Condition
Neurosurgical park bench position surgery
Classification by specialty
| Neurosurgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To scrutinize the ramifications of implementing preventative measures against perioperative pressure injuries in the context of neurosurgical park bench positioning. Within the park bench orientation, wherein the cranium and a segment of the upper torso extend beyond the surgical table, the contact surface is notably restricted as compared to the conventional lateral position, consequently increasing the risk of pressure injuries.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the number of post-operative pressure injuries. The secondary endpoints were the number of postoperative skin disorders and the number of postoperative neurological disorders.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study was conducted at a medical center between January 2017 and March 2023. All participants were 20 years of age or older at the time of neurosurgery park bench position surgery under general anesthesia.
Key exclusion criteria
The exclusion criteria were children, emergency surgery, and patients with a history or family history of malignant hyperthermia.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Hara |
Organization
National Hospital Organization Nagasaki Medical Center
Division name
Operation Center
Zip code
856-8562
Address
Kubara 2-1001-1, Omura, Nagasaki 856-8562, Japan
TEL
+81957523121
haraken1124@gmail.com
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Hara |
Organization
National Hospital Organization Nagasaki Medical Center
Division name
Operation Center
Zip code
8568562
Address
Kubara 2-1001-1, Omura, Nagasaki 856-8562, Japan
TEL
+81957523121
Homepage URL
haraken1124@gmail.com
Sponsor or person
Institute
National Hospital Organization Nagasaki Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Nagasaki Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Nagasaki Medical Center Ethics Review Committee
Address
Kubara 2-1001-1, Omura, Nagasaki 856-8562, Japan
Tel
+81957523121
haraken1124@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
56
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The primary endpoint was the number of postoperative pressure ulcers. Secondary endpoints were the number of postoperative skin lesions and postoperative neuropathy. Decubitus ulcers were determined according to the National Pressure Ulcer Advisory Panel (NPUAP) classification19) . Preoperative clinical findings (age, gender, height, weight, BMI, ASA classification), preoperative physical findings (nutritional status, paralysis, edema), intraoperative factors (operation time, anesthesia time, blood loss, fluid volume, urine output, mean intraoperative pressure in the axilla and greater trochanter, mean central temperature), postoperative factors (postoperative pressure ulcer and skin lesions in the axilla and greater trochanter, occurrence of pressure ulcer and skin lesions in the axilla and greater trochanter), and the number of patients who underwent surgery. postoperative pressure ulcers and skin lesions in the axilla and greater trochanter, postoperative pressure ulcers and skin lesions outside the axilla and greater trochanter, and postoperative neurological damage) were collected. Postoperative reactive hyperemia was counted if it persisted for more than 15 minutes, taking into account the time between the end of surgery and leaving the operating room.
Management information
Registered date
| 2024 | Year | 01 | Month | 01 | Day |
Last modified on
| 2024 | Year | 01 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060774
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