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Clinical Trials/NCT00676858
NCT00676858CompletedNot Applicable

Gas Embolism With Use of Argon Plasma Coagulation

Beth Israel Deaconess Medical Center1 site in 1 country42 target enrollmentStarted: July 2008Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
1
Primary Endpoint
incidence of gas bubbles with use of APC
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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).

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

incidence of gas bubbles with use of APC

Time Frame: end of procedure

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adnan Majid

Associate Professor of Medicine

Beth Israel Deaconess Medical Center

Study Sites (1)

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Gas Embolism With Use of Argon Plasma... | Clinical Trial