A prospective study to evaluate the safety and effectiveness of the system for early detection of pressure injury in hyperbaric oxygen therapy

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005911

Enrollment

200

Registered

2021-02-19

Start date

2021-08-26

Completion date

Unknown

Last updated

2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : 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:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

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

Design outcomes

Primary

Measure	Time frame
Modified Edmond’s Score	—

Secondary

Measure	Time frame
Ear pain and pain scale value (0~10)	—

Countries

Korea, Republic of

Contacts

Public ContactKang Reun

Hallym University

kangpoorun@naver.com+82-31-8086-3200

Outcome results