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| Name | Class |
|---|---|
| The Second Artillery General Hospital | OTHER |
| The 306 Hospital of People's Liberation Army | OTHER |
| First Hospitals affiliated to the China PLA General Hospital | OTHER_GOV |
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PFCs (perfluorocarbons, PFC), an ideal liquid respiratory media, has special chemical and biological properties, including high solubility of gas, swiftness of carrying and release, low surface tension, high proportion, almost non-absorbing and non-metabolic characteristics in the body. On the basis of the strong animal data suggesting the efficacy of PFC vapor inhalation in models of lung injury, we performed a randomized clinical trial comparing PFC vapor inhalation with conventional mechanical ventilation(CMV)in patients with Acute Lung Injury/Acute Respiratory Distress Syndrome(ALI/ARDS). The investigators will apply the Invasive Mechanical Ventilation (IMV) to the vaporized perfluorocarbon inhalation, objectively evaluate its curative effect on the acute respiratory distress syndrome, and meanwhile assess the safety of PFC.
Based on the invasive mechanical ventilation (IMV) treatment of ALI/ARDS, the therapeutic action of vaporized PFC inhalation will be evaluated on the treatment of ALI/ARDS patients, and the safety of vaporized PFC inhalation on the treatment of ALI/ARDS. The Test group will make a timing and fix quantify inhalation of PFC, while the control group will be treated with the inhalation of water for injection. The general condition of patients will be assessed by monitoring their vital signs, hematology testing and APACHE II score, etc. Main outcome measures include the oxygenation index, respiratory mechanics; secondary outcomes include ventilator-free days, 28-day mortality and so on.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perfluorocarbon | Experimental |
| |
| Sterile Water for Injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perfluorocarbon | Drug | Vaporized PFC Inhalation 100ml/8h for 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| oxygenation index, respiratory mechanics | oxygenation index and respiratory mechanics will be abtained before and 1, 2, 4h after every inhalation, | three years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | ventilator-free days, 28-day mortality | three years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhixin Liang, M.D. | Contact | 86-10-13651205567 | 13651205567@163.com | |
| Chen Yang, M.D. | Contact | 86-10-18618333365 | ycmarcia@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Liangan Chen, M.D. PHD. | Chinese PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 306 Hospital of PLA | Recruiting | Beijing | Beijing Municipality | 100000 | China | |
| Chinese PLA General Hospital |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055370 | Lung Injury |
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| ID | Term |
|---|---|
| D005466 | Fluorocarbons |
| D007267 | Injections |
| ID | Term |
|---|---|
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| General Hospital of Chinese Armed Police Forces |
| OTHER |
| Beijing Shijitan Hospital, Capital Medical University | OTHER |
| Air Force General Hospital of the PLA | OTHER_GOV |
| 309th Hospital of Chinese People's Liberation Army | OTHER |
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| Sterile Water for Injection |
| Drug |
Inhalation of Sterile Water for Injection, 100ml/8h for 5 days |
|
| Recruiting |
| Beijing |
| Beijing Municipality |
| 100853 |
| China |
| D004333 |
| Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |