One-Lung Ventilation in the Morbidly Obese Patient: Comparison of Double Lumen Versus Bronchial Blockers

NCT ID: NCT00813176

Last Updated: 2018-06-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study is to determine whether the double-lumen endotracheal tube or the standard single-lumen tracheal tube, with an Arndt® blocker, is superior in providing one lung ventilation during thoracic surgery.

Detailed Description

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The purpose of the study is to compare a double lumen tube versus the standard single-lumen tracheal tube, with an Arndt® blocker, in the morbidly obese patient who requires one-lung ventilation during surgery. The objects is to determine which device is best for intubation and is most effective in terms of optimal positioning of the device, of lung collapse, and quality of lung isolation.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Double Lumen Endotracheal Tube

We used a device called a double lumen tube ( DLT Broncho-Cath®). It is a bifurcated endotracheal tube designed to independently collapse the operated lung.

Group Type ACTIVE_COMPARATOR

Double Lumen Endotracheal Tube

Intervention Type DEVICE

Arndt Bronchial Blocker

We used a device called a bronchial blocker (9 Fr Arndt® blocker) along with a standard single-lumen tracheal tube (8.0-9.0 mm ID). The Arndt bronchial blocker is a single device, with a distal balloon that is passed thru the single lumen endotracheal once the patient is intubated. The Arndt bronchial blocker is designed to collapse the operated lung.

Group Type ACTIVE_COMPARATOR

Arndt Bronchial Blocker

Intervention Type DEVICE

Interventions

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Double Lumen Endotracheal Tube

Intervention Type DEVICE

Arndt Bronchial Blocker

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject undergoing thoracic or esophageal surgery requiring one-lung ventilation.
2. Subject is \>18 years of age.
3. Subject's BMI \> 35.

Exclusion Criteria

1. Subject \< 18 years of age.
2. Subject's BMI \< 35.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Javier H Campos

OTHER

Sponsor Role lead

Responsible Party

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Javier H Campos

Professor in Anesthesia

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Javier H Campos, MD

Role: PRINCIPAL_INVESTIGATOR

Iowa Health Care

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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200701755

Identifier Type: -

Identifier Source: org_study_id

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