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

Not Applicable

Completed

• Conditions: Intubation Complication; Intubation, Difficult
• Interventions: Device: Tranditional fiberoptic bronchoscopy; Device: Modified fiberoptic bronchoscopy; Device: Flexible Trachway intubating stylet

• Registration Number: NCT02364622
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2013-10
• Study Start: 2013-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-17
• Last Update Submitted: 2015-02-17
• Study First Posted: 2015-02-18
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranditional fiberoptic bronchoscopy	Tranditional fiberoptic bronchoscopy	The accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by traditional fiberoptic bronchoscopy.
Modified fiberoptic bronchoscopy	Modified fiberoptic bronchoscopy	The accurate placement of left-sided double lumen endobronchial tube into the left main bronchus was facilitated by modified fiberoptic bronchoscopy.
Flexible Trachway intubating stylet	Flexible Trachway intubating stylet	We used Flexible Trachway intubating stylet to facilitate the accurate placement of left-sided double lumen endobronchial tube into the left main bronchus.

Primary Outcome Measures

Name	Time	Method
Main outcome measure is the successful rate of the first accurate placement of left-sided DLT in the trachea	12 month

Secondary Outcome Measures

Name	Time	Method
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	12 month	MAP was measured before intubation, and after intubation 1, 3,and 5 min.
The outcome measure is the heart rate (HR) during intubation period	12 month	HR was measured and recorded before intubation, and after intubation 1, 3,and 5 min
The outcome measure is the incidence of hypoxemia	12 month	Hypoxemia was defined as SPO2 less than 90%. Hypoxemia was recorded during the intubation period.
The outcome measure is the incidence of hoarseness	12 month	Hoarseness was observed and evaluated after extubation and patient regained consciousness
The outcome measure is the incidence of sore throat	12 month	Sore throat was observed and evaluated after extubation and patient regained consciousness

Trial Locations

Locations (1)

Kaohsiung Medical University chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung City, Taiwan