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Gas Embolism With Use of Argon Plasma Coagulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00676858
First Posted: May 13, 2008
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Adnan Majid, Beth Israel Deaconess Medical Center
  Purpose
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).

Condition
Embolism, Air

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gas Embolism With Use of Argon Plasma Coagulation

Further study details as provided by Adnan Majid, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • incidence of gas bubbles with use of APC [ Time Frame: end of procedure ]

Enrollment: 42
Study Start Date: July 2008
Study Completion Date: July 5, 2011
Primary Completion Date: July 5, 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients referred to tertiary care center
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676858


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Adnan Majid, MD Beth Israel Deaconess Medical Center
  More Information

Responsible Party: Adnan Majid, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00676858     History of Changes
Other Study ID Numbers: 2008P000124
First Submitted: May 9, 2008
First Posted: May 13, 2008
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD was not shared

Keywords provided by Adnan Majid, Beth Israel Deaconess Medical Center:
Embolism
Argon

Additional relevant MeSH terms:
Embolism
Embolism, Air
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases