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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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

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
Active Comparator: Double Lumen Endotracheal Tube Device: Double Lumen Endotracheal Tube
Active Comparator: Arndt Bronchial Blocker 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:

  1. Subject undergoing thoracic or esophageal surgery requiring one-lung ventilation.
  2. Subject is > 18 years of age.
  3. 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

No publications provided

Responsible Party: Javier Campos, MD, University of Iowa Hospitals and Clinics- Department of Anesthesia
ClinicalTrials.gov Identifier: NCT00813176     History of Changes
Other Study ID Numbers: 20701755
Study First Received: December 18, 2008
Last Updated: December 19, 2008
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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013