acute respiratory distress syndrome
Conditions
Interventions
ARDS:No
Sponsors
Zhongshan Hospital affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.The subjects themselves or their family members voluntarily participated in the study and signed the informed consent; 2.Aged 18-80, male or female; 3.A definite diagnosis of acute respiratory distress syndrome (ARDS) (according to the Berlin definition and diagnostic criteria for ARDS), including: 1) onset, new or worsening respiratory symptoms within 1 week; 2) Blurring of both lungs cannot be explained entirely by exudation, atelectasis or nodules; 3) Respiratory failure that cannot be fully explained by heart failure or volume overload; 4) PaO2/FiO2= 5cmH2O; 300 MMHG. 4.The course of disease is less than 96 hours after diagnosis, and the estimated survival time is more than 24 hours; 5.Chest imaging showed bilateral infiltration with pulmonary edema; 6.No clinical manifestations of left ventricular hypertension, or pulmonary wedge pressure PAWP)) <= 18mmHg; 7.In addition, conditions for the application of non-invasive positive pressure ventilation (NPPV) are as follows: 1) Strict monitoring conditions are available in ICU, endotracheal intubation and invasive positive pressure ventilation can be performed immediately in case of deterioration of the condition; 2) The patient does not have organ failure; 3) Concise acute physiological function scoring System ? (SAPS ?) score <= 34. The need for endotracheal intubation depends on the clinical treatment plan.
Exclusion criteria
Exclusion criteria: 1.There are contraindications for fiberbronchoscopy (severe heart disease, cardiac insufficiency, unstable arrhythmia; Abnormal coagulation, massive hemoptysis; Aortic aneurysm, at risk of rupture; Oxygenation index 12); 4.History of malignant tumor (patients with previous basal cell carcinoma of the skin can be included); 5.undergoing hemodialysis or peritoneal dialysis; 6.Screening patients who had experienced lower limb venous thrombosis or pulmonary embolism within the previous 90 days; 7.Acute myocardial infarction occurred within 30 days prior to screening; 8.Neuromuscular diseases that impair natural ventilation, including, but not limited to, spinal cord injury at C5 or higher, AMyotrophic lateral sclerosis, Guillain-Barre syndrome, and myasthenia gravis; 9.Lung transplantation, bone marrow transplantation; 10.Have active immunosuppression, defined as receiving immunosuppressive drugs or having a medical condition related to immunodeficiency. Including: 1) HIV (AIDS or CD4& LT; 200 cells /mm^3); 2) Had received chemotherapy within 6 weeks prior to randomization; 3) Immunosuppressive therapy, including maintenance glucocorticoid therapy (& GT; 40mg/ d prednisolone equivalent dose); 4) Absolute neutrophil count < 500 cells/mm^3. The conditions that can still be included in the group are: 1) < 1 week of short-term systemic (intravenous or oral) steroid therapy with topical steroids for skin conditions; 11.Patients receiving cardiopulmonary bypass support (ECMO) or high-frequency oscillatory ventilation; 12.Unwilling to accept protective ventilation (minimum tidal volume 6ml/kg PBW) or fluid management regiments; 13.Have a history of epilepsy requiring continuous anticonvulsant therapy or have received anticonvulsant therapy within the past 3 years; 14.Hepatitis B, C, AIDS, syphilis; 15.Female patients of childbearing age are pregnant, breast-feeding or have pregnancy intention within the past 1 year; 16.Other clinical trials are under way; 17.Inability to understand research protocols.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day case fatality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intestinal pulmonary microflora expression; | — |
Countries
China
Contacts
Public ContactFang Hao
Outcome results
None listed