Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Unknown

Conditions: Interstitial Disease; Lung Diseases

Treatments: Procedure: Cryoprobe

Study type: Interventional

Funder types: Other

Identifiers

NCT02611297

IIBSP-CRI-2013-142

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Transbronchial lung biopsy with cryoprobe

Other group

Treatment:

Procedure: Cryoprobe