Transbronchial Lung Cryobiopsy in Undiagnosed Acute Respiratory Failure

China-Japan Friendship Hospital

Status: Enrolling

Conditions: Acute Respiratory Distress Syndrome; Acute Respiratory Failure

Treatments: Procedure: Transbronchial lung biopsy; Procedure: Transbronchial lung cryobiopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05754866

CJFH-2022-KY-194

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Transbronchial lung cryobiopsy

Experimental group

Treatment:

Procedure: Transbronchial lung cryobiopsy

Transbronchial lung biopsy

Active Comparator group

Treatment:

Procedure: Transbronchial lung biopsy