One-Lung Ventilation in the Morbidly Obese Patient: A Comparison of a Left-Sided Broncho-Cath® Double Lumen Tube With the Arndt® Wire-Guided Blocker

This study has been completed.

Sponsor:

Information provided by:

University of Iowa

ClinicalTrials.gov Identifier:

NCT00813176

First received: December 18, 2008

Last updated: December 19, 2008

Last verified: December 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	December 18, 2008
Last Updated Date	December 19, 2008
Start Date ^ICMJE	March 2007
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 19, 2008)	Successful tube placement [ Designated as safety issue: Yes ] Placement Time [ Designated as safety issue: Yes ] Effectiveness of lung collapse [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00813176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 19, 2008)	Intraoperative oxygenation [ Designated as safety issue: Yes ] Successful Reinflation [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	One-Lung Ventilation in the Morbidly Obese Patient: A Comparison of a Left-Sided Broncho-Cath® Double Lumen Tube With the Arndt® Wire-Guided Blocker
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to determine whether double lumen endotracheal tubes or bronchial blockers are superior to providing one lung ventilation during thoracic surgery.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Obesity
Intervention ^ICMJE	Device: Double Lumen Endotracheal Tube Device: Arndt Bronchial Blocker
Study Arm (s)	Active Comparator: Double Lumen Endotracheal Tube Intervention: Device: Double Lumen Endotracheal Tube Active Comparator: Arndt Bronchial Blocker Intervention: Device: Arndt Bronchial Blocker
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	50
Completion Date	December 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subject undergoing thoracic or esophageal surgery requiring one-lung ventilation. Subject is > 18 years of age. Patient has a BMI > 35
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00813176
Other Study ID Numbers ^ICMJE	20701755
Has Data Monitoring Committee	Yes
Responsible Party	Javier Campos, MD, University of Iowa Hospitals and Clinics- Department of Anesthesia
Study Sponsor ^ICMJE	University of Iowa
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Iowa
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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