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临床试验/NCT04789395
NCT04789395Unknown不适用

Clinical Determination of Patients Who Intersive Care Unit and Clinical Ttreatments Have Finished Receive Ozonetheraphy With Thorax Tomography Regarding to Interstisial Fibrosis

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年9月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
1
主要终点
prevention of pulmonary fibrosis in covid 19 pneumonia patients with ozone therapy

研究概览

简要总结

It is known that enhances wound healing by oxidative stress and supports immune system besides it is cheap and has not any side effects. Aim of the study is to prevent pulmonary fibrosis by using ozone therapy as a supportive therapy on the patients who have pneumonia and ground glass opacity on thorax CT both in ICU and wards. Patients will follow for a year.

详细描述

The patients accepted with the diagnosis of pneumonia in Gaziosmanpaşa TREH, both in ICU and wards have treated with additional ozone therapy beside the normal treathments. In these patients the findings like ground glass opacity in thorax CT regarding to covid 19 were progressed or non changed. In the concern of these opacities turn to pulmonary fibrosis, ozone therapy has used to prevent this undesirable effect. It is known that enhances wound healing by oxidative stress and supports immune system besides it is cheap and has not any side effects.

25 patients included this study. The patients were diagnosed with Covid-19 pneumonia and treated with ozone therapy in intensive care unit and ward. After treatment was done, findings of at least %20-25 ground-glass opacity on thorax ct were the main criteria for enrollment.

The patients' follow-up program time after hospital discharge will be on 1st, 3rd, 6th and 12th month. They will continue to recieve ozon therapy once in a month during one year follow up. Ground-glass opacity rate of thorax ct scan will be recorded as less then %25, %25-50, %50-75 and above %75. Tomographies will be compared with each other and also last thorax ct before hospital discharge. These tomographies will be applied under 80 KV and this will give %40 less dosage according to routine 120 KV scans. If there is an increase in ground-glass opacities compared to the previous one, the scan will be done again on prone position and suspected lesions will be reevaluated. The pulmonary fibrosis findings of the scan will be diagnosed by a well trained radiology doctor. The evaluation of dyspnea will also done during follow-ups. mMRC(medical research council) dyspnea scale will be used for dyspnea status. SpO2 values in room-air will also recorded. FEV1, FVC and FEV1/FVC values will also be recorded to demonstrate respiratory functions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • over 18 years covid 19 pneumonia patients who have ground glass opacity on thorax CT, receiving ozone as adjuvant therapy.

排除标准

  • pregnant patients patients who doesnt treated with ozone(hyperthyroid,pulmonary hypertension, right ventricule failure,glucose 6 P dehydrogenase defficiency

结局指标

主要结局

prevention of pulmonary fibrosis in covid 19 pneumonia patients with ozone therapy

时间窗: 1 year

Ozone as an additional therapy can reduce the fibrosis

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

SİBEL BEKTAŞ

director

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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