Comparison of Fiberoptic Bronchoscopic Intubation Between Silicone and Polyvinylchloride Double Lumen Tube.

Study Overview
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Brief Summary
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One lung ventilation (OLV) is required during thoracic procedure such as lung and esophagus surgery, and carried out by double lumen tube(DLT). Direct insertion of DLT over a fibreoptic bronchoscope (FOB) is considered more difficult and traumatic than that of a single-lumen tube. Recently, One recent simulation study demonstrated that a soft silicone DLT with a flexible, wire-reinforced bronchial tip (Fuji-Phycon tube) may shorten the time to intubation via tube exchange when compared with less compliant, polyvinyochloride(PVC) DLTs such as the Shilly or Rusch DLT. 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 easier than the Shilly tube. In the present study, The investigators aimed to test the hypothesis that the silicone DLT would be easier than PVC DLT with regard to railroading grade over an FOB. Investigators further aimed to compare the intubation time over the FOB between the silicone DLT and PVC DLT.

Official Title
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Comparison of Fiberoptic Bronchoscopic Intubation Between Silicone and Polyvinylchloride Double Lumen Tube.

Conditions
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Intubation;Difficult

Intervention / Treatment
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* Device: Fibreoptic intubation with silicone double lumen tube
* Device: Fibreoptic intubation with PVC double lumen tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiologist physical status 1,2 Exclusion Criteria: abnormal upper airway, gastrointestinal disease, risk of aspiration, BMI > 35

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: silicone DLT<br>Fibreoptic intubation with silicone double lumen tube | Device: Fibreoptic intubation with silicone double lumen tube<br>* Fibreoptic intubation with silicone double lumen tube<br>|
| Experimental: PVC DLT<br>Fibreoptic intubation with PVC double lumen tube | Device: Fibreoptic intubation with PVC double lumen tube<br>* Fibreoptic intubation with PVC double lumen tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| railroading grade | grade of ease of railroading over fibreoptic bronchoscope. no difficulty passing the tube obstruction while passing the tube, relieved by withdrawal and 90 degree counter-clockwise rotation(2-1) or more than 90 degree rotation(2-2) obstruction necessitating more than one manipulation or external laryngeal manipulation direct laryngoscope was required | an average of 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insertion time | time from insertion of FOB into mouth to tube placement into trachea and left main bronchus | an average of 2 minutes | 
| number of patients with trauma around glottis, observed by FOB | glottic trauma observation through FOB outside the tube | an average of 2minutes | 
| number of patients with tube repositioning during the surgery | count of tube repositioning with FOB during the surgery | an average of 3.5 hours | 
| number of patients with complication of hoarseness, sore throat, and swallowing difficulty | hoarseness, sore throat, swallowing difficulty in post-anesthesia care unit | an average of 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fiberoptic intubation, double lumen tube