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
CRIS Registration Number |
KCT0005911 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 2 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Korea Health Industry Development Institute |
Organization Type | Government |
Project ID | 202014X24 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Hallym University |
Organization Type | University |
7. Study Summary
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 |
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8. Study Design
Study Type | Interventional Study |
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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
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 |
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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)
Type of Primary Outcome | Safety | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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