The Safety of Flexible Bronchoscopy in Patients With Pulmonary Hypertension
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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 |
- 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 |
All patients that will undergo a bronchoscopy according to the regular indications during the study period (12 months) will be eligible for the study.
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| Contact: David Shitrit, MD | 972-9-7471556 | davids3@clalit.org.il |
| Israel | |
| Meir Medical Center | Recruiting |
| Kfar Saba, Israel | |
| Contact: David Shitrit, MD | |
| Principal Investigator: David Shitrit, MD | |
| 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 Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013