Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation
Not Applicable
- Conditions
- Interstitial DiseaseLung Diseases
- Interventions
- Procedure: Cryoprobe
- Registration Number
- NCT02611297
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transbronchial lung biopsy with cryoprobe Cryoprobe -
- Primary Outcome Measures
Name Time Method Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe 27 months
- Secondary Outcome Measures
Name Time Method Diagnostic yield of transbronchial lung biopsy (TBLB) obtained by cryoprobes 27 months
Trial Locations
- Locations (3)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Germans Tries i Pujol Hospital
🇪🇸Badalona, Barcelona, Spain