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Clinical Trials/NCT02611297
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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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

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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