- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00986869
The Safety of Flexible Bronchoscopy in Patients With Pulmonary Hypertension
Study of the Safety of Flexible Bronchoscopy in Patients With Pulmonary Hypertension
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 <90% and need of supplemental oxygen within 30 min of a completed procedure), hypotension (mean arterial pressure <60 mm Hg or systolic blood pressure <90 mm Hg for more than 5 min and/or need for administration of intravenous solution or vasopressors), cardiac dysrhythmias (new onset of arrhythmia or worsening of underlying arrhythmia that caused hemodynamic instability and/or required urgent intervention), bleeding, and death.
The amount of bleeding will be estimated as: no bleeding - minimal bleeding that does not require suctioning; mild bleeding - the need to continually suction the airways; moderate bleeding - the need to wedge FB in the segment involved; severe bleeding - the need for additional interventions or transfusion.
Statistical Analysis Results will express as the mean ± SD for continuous variables. Qualitative data will express as the percentage of patients with a 95% confidence interval. Nominal variables will be compared with Pearson's 2 or Fisher's exact test. Continuous outcome variables will be compared using Student's t test or rank-sum tests as appropriate. Statistical significance will be defined as p < 0.05.
Statistical analysis will be performed using a statistical software package (SPSS, version 13.0; SPSS Inc., Chicago, Ill., USA).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: David Shitrit, MD
- Phone Number: 972-9-7471556
- Email: davids3@clalit.org.il
Study Locations
-
-
-
Kfar Saba, Israel
- Recruiting
- Meir Medical Center
-
Principal Investigator:
- David Shitrit, MD
-
Contact:
- David Shitrit, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
echocardiogram
All the patients will undergo a Doppler echocardiogram in the day of the bronchoscopy after the bronchoscopy
|
All the patients will undergo a Doppler echocardiogram in the day of the bronchoscopy after the bronchoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Michael kutuk, Meir Medical Center
Publications and helpful links
General Publications
- Pue CA, Pacht ER. Complications of fiberoptic bronchoscopy at a university hospital. Chest. 1995 Feb;107(2):430-2. doi: 10.1378/chest.107.2.430.
- Colt HG, Prakash UBS, Offord KP: Bronchoscopy in North America: survey by the American Association for Bronchology, 1999. J Bronchol 2000;7:8-25.
- Ernst A, Silvestri GA, Johnstone D; American College of Chest Physicians. Interventional pulmonary procedures: Guidelines from the American College of Chest Physicians. Chest. 2003 May;123(5):1693-717. doi: 10.1378/chest.123.5.1693. No abstract available.
- Pereira W Jr, Kovnat DM, Snider GL. A prospective cooperative study of complications following flexible fiberoptic bronchoscopy. Chest. 1978 Jun;73(6):813-6. doi: 10.1378/chest.73.6.813.
- Guidelines for fiberoptic bronchoscopy in adults. American Thoracic Society. Medical Section of the American Lung Association. Am Rev Respir Dis. 1987 Oct;136(4):1066. doi: 10.1164/ajrccm/136.4.1066. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 128-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Hypertension
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
Heidelberg UniversityMerck Sharp & Dohme LLCRecruitingChronic Thromboembolic Pulmonary Hypertension | Primary Pulmonary Arterial HypertensionGermany
-
University of South FloridaWithdrawnPulmonary Arterial Hypertension | Familial Primary Pulmonary Hypertension | Idiopathic Pulmonary Arterial Hypertension | Primary Pulmonary HypertensionUnited States
-
University of Kansas Medical CenterRecruitingPulmonary Arterial Hypertension | Pulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Pulmonary Hypertension Due to Left Heart Disease | Pulmonary Hypertension, Primary, 4 | Pulmonary Hypertension, Primary, 2 | Pulmonary Hypertension, Primary, 3 | Pulmonary Hypertension, Primary and other conditionsUnited States
-
BayerCompletedPrimary HypertensionChina
-
Vanderbilt University Medical CenterJohns Hopkins UniversityCompletedPulmonary Arterial Hypertension | Idiopathic Pulmonary Arterial Hypertension | Associated Pulmonary Arterial Hypertension | Heritable Pulmonary Arterial HypertensionUnited States
-
Papworth Hospital NHS Foundation TrustMerck Sharp & Dohme LLCCompleted
-
University of ZurichCompletedPulmonary Hypertension | Pulmonary Artery Hypertension | Chronic Thromboembolic Pulmonary HypertensionSwitzerland
-
National Taiwan University HospitalUnknownPulmonary HypertensionTaiwan
Clinical Trials on Doppler echocardiogram
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
Hospital General Universitario Gregorio MarañonCompletedStroke | Thrombosis | Dilated CardiomyopathySpain
-
University Health Network, TorontoPeter Munk Cardiac CentreRecruiting
-
Assiut UniversityNot yet recruiting
-
Hospital General Universitario Gregorio MarañonHospital Clinic of Barcelona; University of SalamancaRecruitingStroke | Dilated Cardiomyopathy | Hypertrophic Cardiomyopathy | Thrombosis CardiacSpain
-
Hospital General Universitario Gregorio MarañonCompletedMyocardial Infarction | Heart Diseases | Stroke | Thrombosis | Acute DiseaseSpain
-
Duke UniversityRecruiting
-
Barts & The London NHS TrustRecruitingAtrial Fibrillation | Functional Mitral Regurgitation | Functional Tricuspid RegurgitationUnited Kingdom
-
Duke UniversityFogarty International Center of the National Institute of Health; Duke Center... and other collaboratorsCompleted
-
CryoLife, Inc.CompletedAortic Valve Stenosis | Aortic Valve Insufficiency | Pulmonary Valve Insufficiency | Pulmonary Valve StenosisUnited States