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The Safety of Flexible Bronchoscopy in Patients With Pulmonary Hypertension

NCT00986869 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2012-03-16

No results posted yet for this study

Summary

Background

Flexible bronchoscopy (FB) is one of the most common invasive procedures performed by pulmonologists (1) . Typically performed under topical anesthesia and conscious sedation, the procedure is considered to be safe, effective and well tolerated in patients with a wide variety of pulmonary diseases (2). Complications associated with the procedure are rare and studies have estimated an incidence of 0.5-4% (3) The most commonly recognized complications include hypoxia, bleeding, bronchospasm, cardiac dysrhythmias, pneumothorax, and vagal reactions (4). Several conditions increase the risk of complications including pre-existent hypoxemia, use of mechanical ventilation, uremia, profound thrombocytopenia, coagulopathy and pulmonary hypertension (PH) (5). Although previous reports suggest that transbronchial biopsies increase the risk for hemorrhage in this population, data are is limited to survey analyses and isolated reports. Recently Guzman et al. reported a retrospective analysis about the safety of FB in PH. (6) They found that FB can be performed safely in patients with mild and moderate PH. However, the study was small and retrospective analysis. Furthermore, there is no consensus regarding levels of pulmonary artery pressure (PAP) considered to be safe for invasive diagnostic interventions such as TBLB or transbronchial needle aspiration.

Objective

To assess the safety of FB in patients with PH and to study the occurrence of complications associated with different diagnostic bronchoscopic procedures.

Conditions

  • Pulmonary Hypertension

Interventions

PROCEDURE

Doppler echocardiogram

All the patients will undergo a Doppler echocardiogram in the day of the bronchoscopy after the bronchoscopy

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Principal Investigators

  • Michael kutuk · Meir Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00986869 on ClinicalTrials.gov