Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation

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.

Study Overview

• Status: Unknown
• Conditions: Lung Diseases; Interstitial Disease
• Intervention / Treatment: Procedure: Cryoprobe

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Virginia Pajares, MD, PhD; Phone Number: +34935565972; Email: vpajares@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic De Barcelona
    • Contact: Carlos Agustí, MD, PhD; Phone Number: +3493 227 54 00; Email: CAGUSTI@clinic.ub.es
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Virginia Pajares, MD, PhD; Phone Number: +34935565792; Email: vpajares@santpau.cat
    • Principal Investigator: Alfons Torrego, M.D.
    • Sub-Investigator: Ana Muñoz, M.D.
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Germans Tries i Pujol Hospital
      • Contact: Felipe Andreo, MD, PhD; Email: fandreo@separ.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Transbronchial lung biopsy with cryoprobe	Procedure: Cryoprobe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events related to transbronchial lung biopsy (TBLB) with cryoprobe	27 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Diagnostic yield of transbronchial lung biopsy (TBLB) obtained by cryoprobes	27 months

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Hospital Clinic of Barcelona; Germans Trias i Pujol Hospital
• Investigators: Principal Investigator: Virginia Pajares, MD, PhD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: May 21, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 19, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Cryobiopsy; Transbronchial lung biopsy; Cryoprobes
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: IIBSP-CRI-2013-142