The Effects of Flexible Intubating Stylet in the Accurate Placement of Double-lumen Endobronchial Tube

Study Overview
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Brief Summary
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The purpose of this study is to determine whether using the flexible Trachway(R) intubating stylet could facilitate and promote the accurate placement of double-lumen endobronchial tube.

Detailed Description
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How to accurately place the left-sided double-lumen endobronchial tube (DLT) in the trachea remains a great challenge for anesthesiologists. Although new upper airway devices, such as flexible Trachway (R), a video-assisted intubating stylet, had been developed for facilitating airway management, the larger size and the complexity of DLT makes the difficulties for accurate placement of DLT blindly. Therefore, the investigators designed this study to investigate the effects of flexibleTrachway(R) intubating stylet in the placement of left-sided DLT in the trachea.

Official Title
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The Effects of Flexible Trachway(R) Intubating Stylet in the Accurate Placement of Left-sided Double-lumen Endobronchial Tube

Conditions
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Intubation Complication, Intubation, Difficult

Intervention / Treatment
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* Device: Tranditional fiberoptic bronchoscopy
* Device: Modified fiberoptic bronchoscopy
* Device: Flexible Trachway 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 |
| --- | --- |
| Sham Comparator: Tranditional fiberoptic bronchoscopy<br>The accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by traditional fiberoptic bronchoscopy. | Device: Tranditional fiberoptic bronchoscopy<br>* The accurate placement of left-sided DLT into the left main bronchus was facilitated by tranditional fiberoptic bronchoscopy.<br>|
| Experimental: Modified fiberoptic bronchoscopy<br>The accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by modified fiberoptic bronchoscopy. | Device: Modified fiberoptic bronchoscopy<br>* The accurate placement of left-sided DLT into the left main bronchus was facilitated by modified fiberoptic bronchoscopy<br>|
| Experimental: Flexible Trachway intubating stylet<br>We used Flexible Trachway intubating stylet to facilitate the accurate placement of left-sided double lumen endobronchial tube into the left main bronchus. | Device: Flexible Trachway intubating stylet<br>* The accurate placement of left-sided DLT into the left main bronchus was faciliated by using flexible Trachway intubating stylet.<br>|

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 accurate placement of left-sided DLT in the trachea |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The outcome measure is the time needed to accurate placement of left-sided DLT in the trachea |  | 12 month | 
| 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 month | 
| 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 month | 
| The outcome measure is the incidence of hypoxemia | Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the intubation period. | 12 month | 
| The outcome measure is the incidence of sore throat | Sore throat was observed and evaluated after extubation and patient regained consciousness | 12 month | 
| The outcome measure is the incidence of hoarseness | Hoarseness was observed and evaluated after extubation and patient regained consciousness | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flexible intubating stylet, double-lumen endobronchial tube