Incidence of Bacteremia Following Argon Plasma Coagulation in Patients With Endobronchial Lesions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01179022
First received: August 8, 2010
Last updated: March 12, 2013
Last verified: March 2012
  Purpose

Incidence of Bacteremia Following Argon Plasma Coagulation in Patients with Endobronchial Lesions


Condition
Bacteremia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Bacteremia Following Argon Plasma Coagulation in Patients With Endobronchial Lesions

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • The bacteremic rate following APC in patients with endobronchial involvment. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: October 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Bacteremia is a well-recognized invasive medical condition. In most cases, it is a transient phenomenon without clinical consequences. In certain patients, such as those with structural cardiac abnormalities, it may lead to the development of infectious endocarditis. According to an American Heart Association statement, routine endocarditis prophylaxis is indicated prior to invasive procedures with relatively high bacteremia rates, such as dental care,certain types of catheterization and rigid bronchoscopy [1].Fibreoptic bronchoscopy, with or without biopsy is not included in this list due to a very low bacteremia rate [1].This even applies to particularly high risk patients with prosthetic valve or previous endocarditis. Yigla et al. assessed the incidence of bacteremia following bronchoscopy and found 6.5% of bacteremia rate. (2) Recently, Steinfort et al. assessed the bacteremia rate following endobronchial ultrasound and found 7% of bacteremia rate following the procedure. All bacterial isolates were typical oropharyngeal commensal organisms. The transbronchial needle aspiration washing culture was positive in 35% of the patients. However, none of the bacteremic patients had clinical features suggestive of infection and no complications were seen among the cohort. (3) No data are available, however about the bacteremic rate following interventional bronchoscopy for endobronchial obstruction and advance lung carcinoma. In these cases, palliative setting of alleviating central airway obstruction, laser resection, electrocautery, argon plasma coagulation and stenting are techniques that can provide immediate relief.

Argon plasma coagulation (APC) is uses ionize argon gas jet flow to conduct electrons allowing a noncontact mode of treatment (lightning effect). (4, 5) APC has been popular in gastrointestinal endoscopy for superficial coagulation of large mucosal surfaces. The argon gas quite flexibly flows around bends and corners. Coagulated tissue has a higher resistance that automatically drives the argon gas flow away to nearby untreated tissue. An immediate effect really can be seen during electrocautery treatment, which corresponds well with the histological effect of coagulative necrosis.

We therefore conduct a prospective study to assess the bacteremic rate following APC in patients with endobronchial involvement.

  Eligibility

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

50 patients that undergo bronchoscopy with the use of APC

Criteria

Inclusion Criteria:

  • All patients that undergo bronchoscopy with the use of APC

Exclusion Criteria:

  • All patients under 18 years old All Patients with evidence of current respiratory infection or febrile illnesses and those that will receive antibiotic therapy within a week prior to the bronchoscopy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01179022

Locations
Israel
Meir MC
Kfar Saba, Israel, 49100
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: DAVID SHITRIT, MD Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01179022     History of Changes
Other Study ID Numbers: MMC10-137-10.CTIL
Study First Received: August 8, 2010
Last Updated: March 12, 2013
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Meir Medical Center:
Bacteremia
Argon Plasma Coagulation
Endobronchial Lesions

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014