Gas Embolism With Use of Argon Plasma Coagulation

Embolism, Air Clinical Trial

Official title:

Gas Embolism With Use of Argon Plasma Coagulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676858
• Other study ID #: 2008P000124
• Status: Completed
• Phase: N/A
• First received: May 9, 2008
• Last updated: March 24, 2017
• Start date: July 2008
• Est. completion date: July 5, 2011

Study information

• Verified date: March 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 5, 2011
• Est. primary completion date: July 5, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Embolism, Air

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of gas bubbles with use of APC		end of procedure