BacteremiaNCT01179022
Incidence of Bacteremia Following Argon Plasma Coagulation in Patients With Endobronchial Lesions
An observational study of Bacteremia, run by Meir Medical Center at 1 site in Israel.
Trial summary
Incidence of Bacteremia Following Argon Plasma Coagulation in Patients with Endobronchial Lesions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 patients that undergo bronchoscopy with the use of APC
Who may be able to join
- All patients that undergo bronchoscopy with the use of APC
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Incidence of Bacteremia Following Argon Plasma Coagulation in Patients with Endobronchial Lesions
Read the 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.
- Conditions
- Bacteremia
- Keywords
- Bacteremia, Argon Plasma Coagulation, Endobronchial Lesions
- Medical subject headings
- Bacteremia
What is being measured
The primary outcome is the main question the study is designed to answer.
The bacteremic rate following APC in patients with endobronchial involvment.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DAVID SHITRIT, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179022
- Sponsor's protocol ID
- MMC10-137-10.CTIL
- Status last verified
- Mar 2012
- First submitted
- 8 Aug 2010
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matveychuk A, Guber A, Talker O, Shitrit D. Incidence of bacteremia following bronchoscopy with argon plasma coagulation: a prospective study. Lung. 2014 Aug;192(4):615-8. doi: 10.1007/s00408-014-9583-8. Epub 2014 Apr 27.
PubMed 24770443
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Bacteremia Following Argon Plasma Coagulation in Patients With Endobronchial Lesions
- ClinicalTrials.gov ID
- NCT01179022
- Acronym / sponsor ID
- MMC10-137-10.CTIL
- Conditions
- Bacteremia
- Keywords
- Bacteremia, Argon Plasma Coagulation, Endobronchial Lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Incidence of Bacteremia Following Argon Plasma Coagulation in Patients with Endobronchial Lesions
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients that undergo bronchoscopy with the use of APC
Key inclusion criteria (1 listed)
- All patients that undergo bronchoscopy with the use of APC
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The bacteremic rate following APC in patients with endobronchial involvment.
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
- Derived from this study: PubMed 24770443Matveychuk A, Guber A, Talker O, Shitrit D. Incidence of bacteremia following bronchoscopy with argon plasma coagulation: a prospective study. Lung. 2014 Aug;192(4):615-8. doi: 10.1007/s00408-014-9583-8. Epub 2014 Apr 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DAVID SHITRIT, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The bacteremic rate following APC in patients with endobronchial involvment. (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01179022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2013.