Cryoprobe Transbronchial Lung Biospy in Patients With Mechanical Ventilation

NCT ID: NCT02611297

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Lung Diseases Interstitial Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Transbronchial lung biopsy with cryoprobe

Group Type OTHER

Cryoprobe

Intervention Type PROCEDURE

Interventions

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Cryoprobe

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Virginia Pajares, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Germans Tries i Pujol Hospital

Badalona, Barcelona, Spain

Site Status RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status RECRUITING

Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Virginia Pajares, MD, PhD

Role: CONTACT

+34935565972

Facility Contacts

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Felipe Andreo, MD, PhD

Role: primary

Virginia Pajares, MD, PhD

Role: primary

+34935565792

Carlos Agustí, MD, PhD

Role: primary

+3493 227 54 00

Other Identifiers

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IIBSP-CRI-2013-142

Identifier Type: -

Identifier Source: org_study_id