Hyperbaric Oxygen Radiation Tissue Injury Study - VIII (Prophylaxis)

Baromedical Research Foundation (USA)0 个研究点目标入组 38 人开始时间: 2008年10月17日最近更新: 2019年2月11日

适应症

试验速览

•1. Both males and females between the ages of 18 and 70 years
•2. Patients whose cancer treatment included radiotherapy and who are at risk for post-operative healing complications, manifesting as one or more of the medical history or diagnostic criteria listed below:
•2.1. High risk for radiation tissue injury/healing complications:
•2.1.1. 5,000 cGy (50 Gray or 5,000 rads) radiotherapy and greater than 6 months from completion of radiotherapy
•2.1.2. Tissue hypoxia (transcutaneous oximetry recorded below 40 mmHg within the previous radiation portal)

•1. Pregnancy
•2. Ulceration within the previously irradiated field/planned surgical site
•3. Reactive airway disease
•4. Radiographic evidence of pulmonary blebs or bullae
•5. Untreated pneumothorax
•6. Ejection fraction less than 35%
•7. History of seizures (except childhood febrile seizures)
•8. Cardiovascular instability
•9. Mechanical ventilator support
•10. Unable to follow simple commands
•11. Not orientated to person, place, time
•12. Participating as a subject in any other medical or biomedical research project (if previously involved as a subject, sufficient time must have elapsed to permit wash out of any investigational agent)

发起方

Baromedical Research Foundation (USA)