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

Study Overview
=================
Brief Summary
-----------------
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
-----------------
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.

Official Title
-----------------
One-Lung Ventilation in Morbidly Obese Patients:

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: Double Lumen Endotracheal Tube
* Device: Arndt Bronchial Blocker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject undergoing thoracic or esophageal surgery requiring one-lung ventilation. Subject is >18 years of age. Subject's BMI > 35. Exclusion Criteria: Subject < 18 years of age. Subject's BMI < 35.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Double Lumen Endotracheal Tube<br>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<br> <br> |
| Active Comparator: Arndt Bronchial Blocker<br>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<br> <br> |

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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, One-Lung Ventilation, Anesthesia, Thoracic, One-lung ventilation in the morbidly obese patient