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

August 8, 2010
March 12, 2013
October 2010
October 2012   (final data collection date for primary outcome measure)
The bacteremic rate following APC in patients with endobronchial involvment. [ Time Frame: Two years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01179022 on ClinicalTrials.gov Archive Site
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Incidence of Bacteremia Following Argon Plasma Coagulation in Patients With Endobronchial Lesions
Incidence of Bacteremia Following Argon Plasma Coagulation in Patients With Endobronchial Lesions

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

50 patients that undergo bronchoscopy with the use of APC

Bacteremia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01179022
MMC10-137-10.CTIL
Yes
Meir Medical Center
Meir Medical Center
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Principal Investigator: DAVID SHITRIT, MD Meir Medical Center
Meir Medical Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP