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OpenTrials
Completed

NCT Number: NCT00676858

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).

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Key information

Conditions

Embolism, Air Cardiovascular Diseases Embolism Embolism and Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. incidence of gas bubbles with use of APC

    Time frame: end of procedure

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 13, 2008
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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