Gas Embolism With Use of Argon Plasma Coagulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00676858
First received: May 9, 2008
Last updated: April 21, 2010
Last verified: April 2010
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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 ]

Estimated Enrollment: 75
Study Start Date: July 2008
Estimated Primary Completion Date: June 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Adnan Majid M.D., Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00676858     History of Changes
Other Study ID Numbers: 2008P-000124
Study First Received: May 9, 2008
Last Updated: April 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Embolism
Argon

Additional relevant MeSH terms:
Embolism
Embolism, Air
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014