NCT02611297
Unknown
Not Applicable
Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau3 sites in 1 country15 target enrollmentNovember 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lung Diseases
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Enrollment
- 15
- Locations
- 3
- Primary Endpoint
- Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the the diagnostic yield and safety of transbronchial lung biopsies (TBLB) with cryoprobe in patients with mechanical ventilation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥18 years old
- •Patients with mechanical ventilation.
- •Patients with diffuse lung disease of unknown etiology.
- •Need for confirming/excluding a diagnosis, with therapeutical and prognosis implications.
- •Inform consent signed by family.
Exclusion Criteria
- •Use of anticoagulant therapy or presence of a coagulation disorder (abnormal platelets counts, international normalized ratio \> 1.5).
- •Comorbidities that could increase the risk of the TBLB.
- •Bullous emphysema.
- •Hemoptysis, pneumothorax.
- •Severe respiratory insufficiency requiring PEEP \>12 cm H2O
Outcomes
Primary Outcomes
Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe
Time Frame: 27 months
Secondary Outcomes
- Diagnostic yield of transbronchial lung biopsy (TBLB) obtained by cryoprobes(27 months)
Study Sites (3)
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