The Safety of Flexible Bronchoscopy in Patients With Pulmonary Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00986869
First received: September 23, 2009
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Pulmonary Hypertension
Procedure: Doppler echocardiogram

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of the Safety of Flexible Bronchoscopy in Patients With Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • The primary outcome will be the incidence of complications after FB. Complications will define as hypoxemia, hypotension cardiac dysrhythmias, bleeding, and death. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
echocardiogram
All the patients will undergo a Doppler echocardiogram in the day of the bronchoscopy after the bronchoscopy
Procedure: Doppler echocardiogram
All the patients will undergo a Doppler echocardiogram in the day of the bronchoscopy after the bronchoscopy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients that will undergo a bronchoscopy according to the regular indications during the study period (12 months) will be eligible for the study.

Criteria

Inclusion Criteria:

  • All patients that will undergo a bronchoscopy according to the regular indications during the study period (12 months) will be eligible for the study.

Exclusion Criteria:

  • Exclusion criteria will be age under 18 years and patients who are unable to obtain informed consent.
  • Patients with known severe pulmonary hypertension (PAP above 70 mmHg) will be exclude from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986869

Contacts
Contact: David Shitrit, MD 972-9-7471556 davids3@clalit.org.il

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: David Shitrit, MD         
Principal Investigator: David Shitrit, MD         
Sponsors and Collaborators
Meir Medical Center
Investigators
Study Chair: Michael kutuk Meir Medical Center
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00986869     History of Changes
Other Study ID Numbers: 128-09
Study First Received: September 23, 2009
Last Updated: March 15, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Safety
Bronchoscopy
Pulmonary
Hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014