Acute Respiratory Distress Syndrome, Acute Respiratory Failure
Conditions
Brief summary
In patients with acute hypoxemic respiratory failure whose diagnosis is not established after initial evaluation, obtaining a histopathological diagnosis may improve the patients' prognosis. In our previous retrospective-controlled study, transbronchial lung cryobiopsy (TBLC) can lead to an increased chance of establishing a diagnosis compared with transbronchial lung biopsy (TBLB), with an acceptable safety profile. Therefore, further prospective randomized controlled studies exploring whether TBLC leads to improved prognosis for such patients are warranted.
Interventions
PROCEDURETransbronchial lung cryobiopsy
Lung tissue was obtained by transbronchial lung cryobiopsy for subsequent pathology and clinical diagnosis.
PROCEDURETransbronchial lung biopsy
Lung tissue was obtained by transbronchial lung biopsy for subsequent pathology and clinical diagnosis.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of acute hypoxemic respiratory failure 2. Routine assessments \[including bronchoscopy, bronchoalveolar lavage fluid cytology and pathogenic (including pathogenic mNGS) tests, blood tests, etc.\] do not clarify the etiology, or there is an unexplained disease process 3. Imaging shows a multi-lobar segmental distribution of ground glass opacity with or without consolidations 4. Patients' families agreed to participate in the study and signed an informed consent form
Exclusion criteria
1. Significant hemodynamic instability 2. Uncorrectable coagulopathy 3. Severe pulmonary hypertension 4. Acute coronary syndrome 5. Intermediate-high-risk acute pulmonary embolism 6. Acute phase of stroke 7. Severe emphysema 8. Aortic dissection and massive gastrointestinal bleeding 9. Other conditions that are not suitable for participation in the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | 7 days after procedure | The diagnostic yield of each procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 28 and 60 days | The 28-day and 60-day of patients in each group. |
| Incidence of procedure related adverse events | 3 days after procedure | Procedure related death, procedure related hemodynamic and respiratory instability, airway bleeding, pneumothorax and other procedure related adverse events. |
| Hospital stay | up to 60 days | Length of hospital stay including ICU and general ward of respiratory medicine. |
| Organ support | up to 60 days | Length of organ support (days). |
Countries
China
Contacts
Primary ContactQingyuan Zhan, M.D.
Outcome results
None listed