Gas Embolism With Use of Argon Plasma Coagulation

NCT ID: NCT00676858

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-07-05

Brief Summary

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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

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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.

Conditions

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Embolism, Air

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Adnan Majid

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adnan Majid, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2008P000124

Identifier Type: -

Identifier Source: org_study_id

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