Gas Embolism With Use of Argon Plasma Coagulation

This study is currently recruiting participants.

Verified by Beth Israel Deaconess Medical Center, September 2008

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00676858

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

MedlinePlus related topics: Gas

U.S. FDA Resources

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

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

Primary Outcome Measures:

incidence of gas bubbles with use of APC [ Time Frame: end of procedure ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	75
Study Start Date:	July 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676858

Contacts

Contact: Adnan Majid, MD

617-632-8353

amajid@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
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:	Beth Israel Deaconess Medical Center ( Adnan Majid M.D. )
Study ID Numbers:	2008P-000124
Study First Received:	May 9, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00676858
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Embolism
Argon

Study placed in the following topic categories:

Embolism, Air
Embolism and Thrombosis
Embolism
Vascular Diseases
Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009