The Safety of Flexible Bronchoscopy in Patients With Pulmonary Hypertension

NCT00986869 | Unknown

• 1 other identifier: 128-09
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Safety; Bronchoscopy; Pulmonary; Hypertension

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the incidence of complications after FB. Complications will define as hypoxemia, hypotension cardiac dysrhythmias, bleeding, and death.

  one year

Study Arms (1)

echocardiogram

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

Procedure: Doppler echocardiogram

Interventions

Doppler echocardiogram PROCEDURE

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

echocardiogram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients with known severe pulmonary hypertension (PAP above 70 mmHg) will be exclude from the study.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Related Publications (5)

• Colt HG, Prakash UBS, Offord KP: Bronchoscopy in North America: survey by the American Association for Bronchology, 1999. J Bronchol 2000;7:8-25.

  BACKGROUND

• 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.

  PMID: 12740291 BACKGROUND

• 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.

  PMID: 7842773 BACKGROUND

• 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.

  PMID: 657853 BACKGROUND

• 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.

  PMID: 3662229 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary; Hypertension

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michael kutuk

  Meir Medical Center

  STUDY CHAIR

Central Study Contacts

David Shitrit, MD

CONTACT

972-9-7471556; davids3@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 30, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

IL (1)