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Gas Embolism With Use of Argon Plasma Coagulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00676858
First received: May 9, 2008
Last updated: April 21, 2010
Last verified: April 2010

May 9, 2008
April 21, 2010
July 2008
June 2011   (final data collection date for primary outcome measure)
incidence of gas bubbles with use of APC [ Time Frame: end of procedure ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00676858 on ClinicalTrials.gov Archive Site
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Gas Embolism With Use of Argon Plasma Coagulation
Gas Embolism With Use of Argon Plasma Coagulation

The purpose of this study is to use transesophageal echocardiography (TEE) to determine the incidence, severity, and clinical significance of gas bubbles during argon plasma coagulation (APC).

Gas embolism is a rare but serious complication of APC. We will use TEE to monitor for gas bubbles during APC. APC will be terminated if gas bubbles are associated with ischemic heart rhythms, wall motion abnormalities, or if large gas bubbles are noted in the left ventricle.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

patients referred to tertiary care center

Embolism, Air
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
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June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults (male and female) 18 years of age or older
  • Clinical indication for bronchoscopy (hemoptysis, airway obstruction, tumor excision, granulation tissue that is impairing endobronchial stent performance)
  • Ability of the patient or proxy to read, comprehend, and sign informed consent document.

Exclusion Criteria:

  • Presence of esophageal disorders that may complicate transesophageal echocardiography (strictures, varices, fistula, prior esophageal surgery)
  • Presence of coagulopathy or other bleeding diathesis
  • Inability to tolerate brief periods of apnea
  • Presence of pulmonary vascular disease
  • Pregnant women will not be included in this study because the potential fetal hypoxemia is not an acceptable risk.
  • No exclusions will be made based on gender or race.
Both
18 Years and older
No
Contact: Adnan Majid, MD 617-632-8353 amajid@bidmc.harvard.edu
United States
 
NCT00676858
2008P-000124
Yes
Adnan Majid M.D., Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
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Principal Investigator: Adnan Majid, MD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
April 2010

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