The Efficacy of Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of Trachway(R) compared with direct laryngoscope in tracheal intubation of double-lumen endobronchial tube.

Detailed Description
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Intubation with the double-lumen endobronchial tube (DLT) remains a great challenge for anesthesiologists. Although new upper airway devices, such as Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management. The larger size and the complexity of DLT than single-lumen tube (SLT) makes the difficulties for DLT intubation. Therefore, the investigators designed this study to investigate the effects of Trachway(R)compared with direct laryngoscope in DLT intubation.

Official Title
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The Comparison of Direct Laryngoscope and Trachway (R) Intubating Stylet in the Insertion of the Double Lumen Endobronchial Tube

Conditions
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Anesthesia Intubation Complications

Intervention / Treatment
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* Device: Direct laryngoscope (Macintoish laryngoscope)
* Device: Trachway(R) intubating stylet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with American Society of Anesthesiologists physical status I-III More than 18 years of age Requiring DLT for thoracic surgery Exclusion Criteria: risk of regurgitation and pulmonary aspiration history of gastroesophageal reflux, pregnancy scheduled tracheostomy and postoperative prolonged ventilation in ICU patients with limited neck extension (< 35°) a distance between the tip of the patient's mandible and hyoid bone of less than 7 cm a sternomental distance of less than 12.5 cm with the head fully extended mouth can not open

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Direct laryngoscope<br>Direct laryngoscope was used to facilitate the intubation of left-sided double lumen endobronchial tube. | Device: Direct laryngoscope (Macintoish laryngoscope)<br>* Direct laryngoscope was used to facilitate the intubation of left-sided DLT.<br>* Other names: Macintoish laryngoscope;|
| Experimental: Trachway(R) intubating stylet<br>Trachway(R) intubating stylet was used to facilitate left-sided double lumen endobronchial tube intubation. | Device: Trachway(R) intubating stylet<br>* Trachway(R) intubating stylet was used to facilitate the intubation of left-sided DLT.<br>* Other names: The Clarus Video System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main outcome measure is the successful rate of the first intubation |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The outcome measure is the time needed to insert the DLT |  | 12 months | 
| The outcome measure is mean blood pressure (MAP) during intubation period | MAP was measured before intubation, and after intubation 1, 3,and 5 min. | 12 months | 
| The outcome measure is the heart rate (HR) during intubation period | HR was measured and recorded before intubation, and after intubation 1, 3,and 5 min. | 12 months | 
| The outcome measure is the incidence of hypoxemia. | Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the period of intubation. | 12 months | 
| The outcome measure is the incidence of sore throat. | Sore throat was observed and evaluated after extubation and patient regained consciousness. | 12 months | 
| The outcome measure is the incidence of hoarseness. | Hoarseness was observed and evaluated after extubation and patient regained consciousness. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trachway(R) intubating stylet, Left sided double lumen endobronchial tube, Efficacy, Intubation complication