Using cryobiopsy to diagnose undiagnosed acute respiratory failure

Transbronchial Lung Biopsy Versus Transbronchial Lung Cryobiopsy in Critically Ill Patients With Undiagnosed Acute Hypoxemic Respiratory Failure: a Multicenter Prospective Study

This study is testing if a new lung biopsy method can help people with unexplained breathing problems get a clearer diagnosis when standard tests don’t work.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China-Japan Friendship Hospital (Academic / other)
• Locations: 6 sites (Beijing and 5 other locations)
• Trial ID: NCT05754866 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of transbronchial lung cryobiopsy (TBLC) in patients suffering from acute hypoxemic respiratory failure when initial diagnostic evaluations fail to establish a clear diagnosis. The study aims to determine if TBLC can improve the chances of obtaining a histopathological diagnosis compared to traditional transbronchial lung biopsy (TBLB), potentially leading to better patient outcomes. Participants will undergo TBLC or TBLB to assess the safety and efficacy of these procedures in diagnosing their condition.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with acute hypoxemic respiratory failure who have not received a clear diagnosis after standard evaluations.

Not a fit: Patients with significant hemodynamic instability, severe pulmonary hypertension, or other serious comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance diagnostic accuracy and improve treatment strategies for patients with acute respiratory failure.

How similar studies have performed: Previous studies have indicated that TBLC may be more effective than TBLB in establishing diagnoses, suggesting a promising avenue for further exploration.

Eligibility criteria

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

Where this trial is running

Beijing and 5 other locations

• China-Japan Friendship Hospital — Beijing, China (Recruiting)
• The Second Xiangya Hospital — Changsha, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, China (Recruiting)
• The Sixth Hospital of Wuhan — Wuhan, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Recruiting)

Study contacts

• Study coordinator: Qingyuan Zhan, M.D.

Conditions Acute Respiratory Failure; Acute Respiratory Distress Syndrome