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

One-Lung Ventilation in Morbidly Obese Patients:

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: Double Lumen Endotracheal Tube; Device: Arndt Bronchial Blocker

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Double Lumen Endotracheal Tube
Active Comparator: 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.	Device: Arndt Bronchial Blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Taken for Endotracheal Tube Placement Procedure.	For each group, the time in minutes required for the anesthesiologist to successfully place the endotracheal tube. Intubation time was recorded as the time from when the tracheal tube passed the vocal cords until the anesthetist concluded that the DLT (Arm 1) or the single-lumen tube with the Arndt blocker (Arm 2) was correctly placed and optimal position was confirmed with the fiberoptic bronchoscope.	This measurement occurred after the patient was in the operating room and the randomization group was determined. This measurement began and ended during the intubation procedure.
Number of Participants in Which the Tube Was Successfully Positioned at First Attempt	Number of participants in each group in which the tube was successfully positioned at first attempt	This data measure was occurred during surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of Lung Collapse	For each group, the number of participants in which lung collapse was evaluated as: (i) good-complete collapse without surgical interference, (ii) fair-total collapse, but with residual air, and (iii) poor-no or partial collapse, lung inflated and interfering with the surgical exposure.	This measure occured during surgery just after intubation.
Time Required to Collapse the Lung	For each group, the mean time for lung isolation/collapse was measured from the institution of one-lung ventilation to the time of total lung collapse.	This measurement occurred during surgery.
Number of Participants With Successful Reinflation	In each group, the number of Participants in which successful lung reinflation occurred.	This occurred during surgery.
Mean Intraoperative Oxygenation During One-lung Ventilation	For each group, the mean intraoperative oxygenation (arterial partial pressure of oxygen measured by arterial blood gases) were taken during two-lung ventilation (baseline) and after 30 min of one-lung ventilation.	This measure occured during surgery.

Collaborators and Investigators

• Sponsor: Javier H Campos
• Investigators: Principal Investigator: Javier H Campos, MD, Iowa Health Care

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: December 18, 2008
• First Submitted That Met QC Criteria: December 19, 2008
• First Posted (Estimate): December 22, 2008

Study Record Updates

• Last Update Posted (Actual): June 4, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Anesthesia; Thoracic; One-Lung Ventilation; One-lung ventilation in the morbidly obese patient
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 200701755