Gas Embolism With Use of Argon Plasma Coagulation

March 24, 2017 updated by: Adnan Majid, Beth Israel Deaconess Medical Center
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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients referred to tertiary care center

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of gas bubbles with use of APC
Time Frame: end of procedure
end of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Investigators

  • Principal Investigator: Adnan Majid, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

July 5, 2011

Study Completion (Actual)

July 5, 2011

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008P000124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD was not shared

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Embolism, Air

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe