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Clinical safety and effectiveness of an early detection system for pressure injury in conjunction with a hyperbaric oxygen chamber

Status Approved

  • First Submitted Date

    2021/02/15

  • Registered Date

    2021/02/19

  • Last Updated Date

    2022/12/30

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005911
    Unique Protocol ID HI20C1281
    Public/Brief Title A prospective study to evaluate the safety and effectiveness of the system for early detection of pressure injury in hyperbaric oxygen therapy
    Scientific Title Clinical safety and effectiveness of an early detection system for pressure injury in conjunction with a hyperbaric oxygen chamber
    Acronym PIHOC
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number HI20C1281
    Approval Date 2020-11-18
    Institutional Review Board Name Hallym University Dongtan Sacred Hospital Institutional Review Board
    Institutional Review Board Address 7, Keunjaebong-gil, Hwaseong-si, Gyeonggi-do
    Institutional Review Board Telephone 031-8086-2160
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Wang Soon Joo
    Title Professor
    Telephone +82-31-8086-3153
    Affiliation Hallym University
    Address 1 Hallymdaehak-gil, Chuncheon, Gangwon-do, Republic of Korea
    Contact Person for Public Queries
    Name Kang Poo Reun
    Title Researcher
    Telephone +82-31-8086-3200
    Affiliation Hallym University
    Address 1 Hallymdaehak-gil, Chuncheon, Gangwon-do, Republic of Korea
    Contact Person for Updating Information
    Name Kang Poo Reun
    Title Researcher
    Telephone +82-31-8086-3200
    Affiliation Hallym University
    Address 1 Hallymdaehak-gil, Chuncheon, Gangwon-do, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 2
    Overall Recruitment Status Completed
    Date of First Enrollment 2021-08-26 Actual
    Target Number of Participant 200
    Primary Completion Date 2022-12-16 , Actual
    Study Completion Date 2022-12-16 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Hallym University Medical Center-Dongtan
    Recruitment Status Completed
    Date of First Enrollment 2021-08-26 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Inha University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2022-08-31 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Korea Health Industry Development Institute
    Organization Type Government
    Project ID 202014X24
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Hallym University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    [Research purpose]
    Safety and effectiveness evaluation and securing of an early detection system for pressure damage linked to a medical hyperbaric oxygen chamber
    [Research hypothesis]
    With the application of a control system for early detection of barotrauma, pressure damage is detected earlier and less frequently than traditional medical examination methods.
    [Research design]
    -Prospective Parallel design : Assign subjects to different treatment groups (group 2)
    -Test group : Pressure damage early detection control system applied
    -Control : Instead of a control system for early detection of barotrauma, a traditional pre-treatment interview was performed.
    [Number of Research Subjects]
    200 (100 test group and 100 control group) expected
    [Assessment Methods]
    - Key observation items : Check the severity of pressure damage in the middle ear (observe twice before and after applying high pressure)
    - Observation method : Direct observation of the otoscope by medical staff
    - 4 evaluation items : Number of discontinued treatment/treatment completion due to pressure injury, otoscopic observation findings (Grade 0-5,) Ear pain (pain scale value), subject satisfaction
    [Expected effect and expected result]
    ○ Technical aspect
    - Advancement of technology by developing early detection system module for pressure damage, the first in Korea
    - Preemption of objective tympanic condition monitoring technology during hyperbaric oxygen treatment
    - Safety verification and export market development through world-class product certification
    - Safety and efficacy verification of treatment by preventing side effects of hyperbaric oxygen therapy
    ○ Economic and industrial aspects
    - Establishment of emergency response system and vitalization of medical device industry
    - Actively contributing to the development of the medical device industry through technological innovation
    - Revitalize the economy by increasing sales and exports
    - Contributing to the creation of local jobs through the creation of new jobs
    ○ Social aspect
    - Increasing carbon monoxide poisoning, large fires, and maritime accidents increase the treatment effect of severe patients
    - National medical benefits spread by increasing the number of hyperbaric oxygen therapy medical treatments every year
    - Promote national health and improve quality of life through continuous expansion of indications
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Medical Device  
    Intervention Description
    Subjects will be assigned to different treatment groups (2 groups) by a prospective parallel design method.
    Test group: Pressure damage early detection control system applied
    Control: Instead of a control system for early detection of barotrauma, a pre-treatment interview
    
    - Both test and control groups pressurized to 2.4 atmospheres during hyperbaric oxygen therapy
    - Both the test group and the control group used the hyperbaric oxygen chamber of the model subject to this study.
    - Apply pre-treatment checklist to both test and control groups
    Number of Arms 2
    Arm 1

    Arm Label

    Pressure damage early detection control system applied

    Target Number of Participant

    100

    Arm Type

    Experimental

    Arm Description

    Pressure damage early detection control system applied. Therefore, the patient undergoes treatment while wearing a terminal that looks like a headphone of the early detection control system for pressure damage, and when pressure damage occurs, the module connected to the hyperbaric oxygen chamber detects pressure damage early and gives a warning. Depending on the warning, the operator of the hyperbaric oxygen chamber will adjust or change the rate of pressure change and take measures such as stopping further hyperbaric oxygen therapy if necessary. In the test group, like the control group, the researcher checks the patient's symptom change under pressure and decompression during treatment, but the early detection of pressure damage control system is expected to detect pressure damage early regardless of symptoms.
    Arm 2

    Arm Label

    Instead of a control system for early detection of barotrauma, a pre-treatment interview

    Target Number of Participant

    100

    Arm Type

    Active comparator

    Arm Description

    Instead of a control system for early detection of barotrauma, an interview is performed before and during the traditional treatment. In particular, due to the nature of pressure damage that occurs in pressure and decompression situations, the symptoms of pressure damage occurring in the patient, such as ear pain during treatment, are checked orally in real time. It is expected that early detection is difficult because there are many cases.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s)    (R00-R99)Symptoms, signs and abnormal clinical and laboratory findings, NEC 

    - Carbon monoxide poisoning - Caisson disease(decompression sickness) - Air embolism - Gas gangrene - Central retinal artery occlusion - Burn of second degree of head and neck, unspecified site - Tissue necrosis after radiation therapy - Diabetes NOS, with diabetic foot ulcer - Sudden idiopathic hearing loss, unilateral
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~65Year

    Description

    - Subjects aged 18 to 65 who do not meet the exclusion criteria
    - Those who fall under medical insurance or academic indications for hyperbaric oxygen therapy
    - Those who voluntarily consent to the clinical trial
    Exclusion Criteria
    - Age other than the age of the subject selection criteria
    - Pregnant woman
    - Pneumothorax or suspected pneumothorax (difficulty breathing, chest pain, etc.)
    - Respiratory symptoms and diseases: upper respiratory infections, Emphysema/COPD
    - High fever
    - Thoracic/Ear Surgery Experience
    - Claustrophobia
    - Other academic and clinical contraindications
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Safety
    Primary Outcome(s) 1
    Outcome
    Modified Edmond’s Score
    Timepoint
    Immediately after hyperbaric oxygen treatment
    Secondary Outcome(s) 1
    Outcome
    Ear pain and pain scale value (0~10)
    Timepoint
    Immediately after hyperbaric oxygen treatment
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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