Acute Respiratory Distress Syndrome Clinical Trial
Official title:
Transbronchial Lung Biopsy Versus Transbronchial Lung Cryobiopsy in Critically Ill Patients With Undiagnosed Acute Hypoxemic Respiratory Failure: a Multicenter Prospective Study
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 30, 2025 |
Est. primary completion date | November 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | China-Japan Friendship Hospital | Beijing | |
China | The Second Xiangya Hospital | Changsha | |
China | The First Affiliated Hospital of Nanchang University | Nanchang | |
China | The First Affiliated Hospital of Soochow University | Suzhou | |
China | The Sixth Hospital of Wuhan | Wuhan | |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou |
Lead Sponsor | Collaborator |
---|---|
China-Japan Friendship Hospital |
China,
Chang CH, Ju JS, Li SH, Wang SC, Wang CW, Lee CS, Chung FT, Hu HC, Lin SM, Huang CC. Feasibility and Safety of Transbronchial Lung Cryobiopsy for Diagnosis of Acute Respiratory Failure with Mechanical Ventilation in Intensive Care Unit. Diagnostics (Basel). 2022 Nov 23;12(12):2917. doi: 10.3390/diagnostics12122917. — View Citation
Gerard L, Bidoul T, Castanares-Zapatero D, Wittebole X, Lacroix V, Froidure A, Hoton D, Laterre PF. Open Lung Biopsy in Nonresolving Acute Respiratory Distress Syndrome Commonly Identifies Corticosteroid-Sensitive Pathologies, Associated With Better Outcome. Crit Care Med. 2018 Jun;46(6):907-914. doi: 10.1097/CCM.0000000000003081. — View Citation
Lim SY, Suh GY, Choi JC, Koh WJ, Lim SY, Han J, Lee KS, Shim YM, Chung MP, Kim H, Kwon OJ. Usefulness of open lung biopsy in mechanically ventilated patients with undiagnosed diffuse pulmonary infiltrates: influence of comorbidities and organ dysfunction. Crit Care. 2007;11(4):R93. doi: 10.1186/cc6106. — View Citation
Papazian L, Doddoli C, Chetaille B, Gernez Y, Thirion X, Roch A, Donati Y, Bonnety M, Zandotti C, Thomas P. A contributive result of open-lung biopsy improves survival in acute respiratory distress syndrome patients. Crit Care Med. 2007 Mar;35(3):755-62. doi: 10.1097/01.CCM.0000257325.88144.30. — View Citation
Philipponnet C, Cassagnes L, Pereira B, Kemeny JL, Devouassoux-Shisheboran M, Lautrette A, Guerin C, Souweine B. Diagnostic yield and therapeutic impact of open lung biopsy in the critically ill patient. PLoS One. 2018 May 25;13(5):e0196795. doi: 10.1371/journal.pone.0196795. eCollection 2018. — View Citation
Wang S, Feng Y, Zhang Y, Tian Y, Gu S, Wu X, Feng Y, Zhao L, Liu M, Wang D, Li Y, Tian Z, Wang S, Huang X, Zhou G, Zhan Q. Transbronchial lung biopsy versus transbronchial lung cryobiopsy in critically ill patients with undiagnosed acute hypoxemic respiratory failure: a comparative study. BMC Pulm Med. 2022 May 4;22(1):177. doi: 10.1186/s12890-022-01966-4. — View Citation
Wang S, Zhou G, Feng Y, Zhang Y, Tian Y, Gu S, Wu X, Li M, Feng Y, Wang D, Li Y, Tian Z, Zhao L, Li M, Chen W, Huang X, Zhan Q. Feasibility of transbronchial lung cryobiopsy in patients with veno-venous extracorporeal membrane oxygenation support. ERJ Open Res. 2022 Dec 19;8(4):00383-2022. doi: 10.1183/23120541.00383-2022. eCollection 2022 Oct. — View Citation
Zhou G, Feng Y, Wang S, Zhang Y, Tian Y, Wu X, Zhao L, Wang D, Li Y, Tian Z, Zhan Q. Transbronchial lung cryobiopsy may be of value for nonresolving acute respiratory distress syndrome: case series and systematic literature review. BMC Pulm Med. 2020 Jun 29;20(1):183. doi: 10.1186/s12890-020-01203-w. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic yield | The diagnostic yield of each procedure. | 7 days after procedure | |
Secondary | Mortality | The 28-day and 60-day of patients in each group. | 28 and 60 days | |
Secondary | Incidence of procedure related adverse events | Procedure related death, procedure related hemodynamic and respiratory instability, airway bleeding, pneumothorax and other procedure related adverse events. | 3 days after procedure | |
Secondary | Hospital stay | Length of hospital stay including ICU and general ward of respiratory medicine. | up to 60 days | |
Secondary | Organ support | Length of organ support (days). | up to 60 days |
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