Transbronchial Lung Cryobiopsy in Undiagnosed Acute Respiratory Failure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Transbronchial lung cryobiopsy
|
Procedure: Transbronchial lung cryobiopsy
Lung tissue was obtained by transbronchial lung cryobiopsy for subsequent pathology and clinical diagnosis.
|
| Active Comparator: Transbronchial lung biopsy
|
Procedure: Transbronchial lung biopsy
Lung tissue was obtained by transbronchial lung biopsy for subsequent pathology and clinical diagnosis.
|
Outcome Measures
Primary Outcome Measures
- Diagnostic yield [7 days after procedure]
The diagnostic yield of each procedure.
Secondary Outcome Measures
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of acute hypoxemic respiratory failure
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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
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Imaging shows a multi-lobar segmental distribution of ground glass opacity with or without consolidations
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Patients' families agreed to participate in the study and signed an informed consent form
Exclusion Criteria:
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Significant hemodynamic instability
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Uncorrectable coagulopathy
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Severe pulmonary hypertension
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Acute coronary syndrome
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Intermediate-high-risk acute pulmonary embolism
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Acute phase of stroke
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Severe emphysema
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Aortic dissection and massive gastrointestinal bleeding
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Other conditions that are not suitable for participation in the clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China-Japan Friendship Hospital | Beijing | China | ||
| 2 | The Second Xiangya Hospital | Changsha | China | ||
| 3 | The First Affiliated Hospital of Nanchang University | Nanchang | China | ||
| 4 | The First Affiliated Hospital of Soochow University | Suzhou | China | ||
| 5 | The Sixth Hospital of Wuhan | Wuhan | China | ||
| 6 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
Sponsors and Collaborators
- China-Japan Friendship Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- CJFH-2022-KY-194