Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation

F

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)

15 participants in 1 patient group

Transbronchial lung biopsy with cryoprobe
Other group
Treatment:
Procedure: Cryoprobe

Trial contacts and locations

3

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Central trial contact

Virginia Pajares, MD, PhD

Data sourced from clinicaltrials.gov

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