Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube in Patients With Semi-regid Neck Collar.

Study Overview
=================
Brief Summary
-----------------
Many intrathoracic procedures demand optimal collapse of the operative lung to facilitate surgical exposure. Single-lung ventilation can be achieved using a double-lumen tube (DLT), a Univent tube, or an independent bronchial blocker. Insertion of a DLT using a direct laryngoscope can be more difficult than that of single-lumen tube (SLT), especially in patients for whom airway difficulty is anticipated. The safest of the proposed methods involves the placement of an SLT with the aid of an fibreoptic bronchoscope (FOB), following which the SLT is replaced with a DLT using an airway exchange technique in these patients. HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible, non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea over the FOB with as much as ease as a standard SLT. In the present study, the investigators aimed to test the hypothesis that the HumanBroncho® DLT would be non-inferior to a standard SLT with regard to intubation time over an FOB in patients with semi-rigid neck collar simulating difficult airway.

Official Title
-----------------
Comparison of Fiberoptic Intubation Between Double Lumen Tube and Single Lumen Tube in Patients With Semi-rigid Neck Collar Immobilization of the Cervical Spine.

Conditions
-----------------
Intubation;Difficult, Thoracic Diseases

Intervention / Treatment
-----------------
* Device: single lumen tube and bronchial blocker
* Device: double lumen tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing thoracic surgery requiring one lung ventilation. American Society of Anesthesiologist, Physical Status 1,2 Exclusion Criteria: abnormality of upper airway gastroesophageal disease risk of aspiration BMI > 35

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single lumen tube and bronchial blocker<br>neck collar apply. fibreoptic intubation with single lumen tube and brochial blocker | Device: single lumen tube and bronchial blocker<br>* neck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.<br>|
| Experimental: Double lumen tube<br>neck collar apply. fibreoptic intubation with double lumen tube | Device: double lumen tube<br>* neck collar apply. fibreoptic intubation with double lumen tube.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation time | the time from the passage of the fibreoptic bronchoscope beyond the teeth, to tracheal tube positioning above the carina. | through study completion, an average of 4 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insertion time | the time from the passage of the fibreoptic bronchoscope beyond the teeth, to fibreoptic bronchoscope positioning above the carina | through study completion, an average of 4 hour | 
| railroading time | the time from fibreoptic bronchoscope positioning above the carina to tracheal tube positioning above the carina. | through study completion, an average of 4 hour | 
| grade of ease of insertion over fibreoptic bronchoscope | 1, no difficulty passing the tube; 2, obstruction while passing the tube, relieved by withdrawal and a 90° counter-clockwise rotation; 3, obstruction necessitating more than one manipulation or external laryngeal manipulation; 4, direct laryngoscopy was required. | through study completion, an average of 4 hour | 
| trauma around the glottis | fibreoptic observation of the glottic bleeding. | through study completion, an average of 4 hour | 
| complication at the post-anesthesia care unit | hoarseness, sore throat, swallowing difficulty | through study completion, an average of 4 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibreoptic intubation, double lumen tube, difficult intubation