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.

Sponsored by:	University of Iowa
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00813176

Purpose

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.

Condition	Intervention
Obesity	Device: Double Lumen Endotracheal Tube Device: Arndt Bronchial Blocker

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Safety/Efficacy Study

Further study details as provided by University of Iowa:

Primary Outcome Measures:

Successful tube placement [ Designated as safety issue: Yes ]
Placement Time [ Designated as safety issue: Yes ]
Effectiveness of lung collapse [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Intraoperative oxygenation [ Designated as safety issue: Yes ]
Successful Reinflation [ Designated as safety issue: Yes ]

Enrollment:	50
Study Start Date:	March 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Double Lumen Endotracheal Tube: Active Comparator	Device: Double Lumen Endotracheal Tube
Arndt Bronchial Blocker: Active Comparator	Device: Arndt Bronchial Blocker

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject undergoing thoracic or esophageal surgery requiring one-lung ventilation.
Subject is > 18 years of age.
Patient has a BMI > 35

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813176

Locations

United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52241

Sponsors and Collaborators

University of Iowa

More Information

Responsible Party:	University of Iowa Hospitals and Clinics- Department of Anesthesia ( Javier Campos, MD )
Study ID Numbers:	20701755
Study First Received:	December 18, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00813176
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Iowa:

Obesity
One-Lung Ventilation
Anesthesia
Thoracic
One-lung ventilation in the morbidly obese patient

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 13, 2009