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The Safety of Flexible Bronchoscopy in Patients With Pulmonary Hypertension

Descriptive Information
Brief Title † The Safety of Flexible Bronchoscopy in Patients With Pulmonary Hypertension
Official Title † Study of the Safety of Flexible Bronchoscopy in Patients With Pulmonary Hypertension
Brief 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.
Detailed Description The Safety of Flexible Bronchoscopy in Patients with Pulmonary Hypertension 1Pulmonary department and 2Devision of Cardiology Affiliated with Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Meir Medical Center, Kfar Saba, Israel 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. Materials and Methods Study Population 100 patients that will undergo a bronchoscopy according to the regular indications during the study period (12 months) will be eligible for the study. Criteria for exclusion 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. Procedural Conduct All procedures will be performing in the bronchoscopy suite of the Pulmonary Department in Meir Medical center. Fluoroscopy will be available for all procedures. FB will be performed by a training pulmonary physician that will be blinded to the echocardiograpgic findings. Oxygen will be administered to all patients to ensure SpO2 >90% prior to the introduction of the bronchoscope. Continuous pulse oximetry, electrocardiogram and noninvasive blood pressure monitoring will be obtained throughout the procedure. Sedation will be achieved using midazolam. Topical anesthesia (was) will be obtained using 2% lidocaine. Study Subjects All the patients will undergo a Doppler echocardiogram in the day of the bronchoscopy after the bronchoscopy. The diagnosis of PH will define as (1) mean PAP (mPAP) >25 mm Hg measured by right heart catheterization (RHC), or (2) right ventricular systolic pressure (RVSP) >40 mm Hg estimated by Doppler echocardiography. PAP will be calculated as the sum of tricuspid regurgitation gradient and estimated right atrial pressure, provided there is no increase in pulmonic valve flow velocity .Maximal tricuspid regurgitation velocity (taken from all available views) will be measured by continuous wave Doppler echocardiography to evaluate the pressure gradient from the right ventricle to the right atrium. Right atrial pressure will be estimated on the basis of inferior vena cava (IVC) size and inspiratory collapse (7,8). Data Collection Data will be collected from all patients including baseline characteristics of age, sex, medications and electrocardiogram. Blood tests including blood count, indication for bronchoscopy, duration and bronchoscopic procedures. All echocardiogram findings will be collected by physicians that will be blinded to the bronchoscpoic details. Outcome Measures The primary outcome will be the incidence of complications after FB. Complications will define as hypoxemia (SpO2
Study Phase N/A
Study Type † Observational
Study Design † Observational Model: Case-Only, Time Perspective: Prospective
Primary Outcome Measure † The primary outcome will be the incidence of complications after FB. Complications will define as hypoxemia, hypotension cardiac dysrhythmias, bleeding, and death.
Secondary Outcome Measure †
Condition † Pulmonary Hypertension
Intervention † ProcedureDoppler echocardiogram
Study Arms / Comparison Groups echocardiogram All the patients will undergo a Doppler echocardiogram in the day of the bronchoscopy after the bronchoscopy
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 100
Start Date † September 2009
Completion Date September 2012
Primary Completion Date August 2012
Eligibility 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.
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† David Shitrit, MD, 972-9-7471556, davids3@clalit.org.il
Location Countries † Israel
Administrative Information
NCT ID † NCT00986869
Organization ID 128-09
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Meir Medical Center
Collaborators ††
Investigators † Study Chair: Michael kutuk, Meir Medical Center
Information Provided By
Verification Date March 2012
First Received Date † September 23, 2009
Last Updated Date March 15, 2012
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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