Modified Angled Tube vs. Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation

Not Applicable

Completed

• Conditions: Intubation, Intratracheal; Thoracic Surgical Procedures
• Interventions: Device: Mallinckrodt endotracheal tube with a modified angle; Device: Mallinckrodt endobronchial tube with a conventional angle

• Registration Number: NCT02190032
• Lead Sponsor: Samsung Medical Center

Brief Summary

The investigators are trying to compare the individually modified-angled tube and the conventional-angled tube in ease of double lumen endotracheal tube insertion and the incidence of related postoperative complications.

Detailed Description

Inserting a double lumen endotracheal tube is somewhat more difficult than a single lumen tube intubation because of its larger outer diameter and the more rigid feature. Moreover, the airway axes (oral-,pharyngeal-, and laryngotracheal axis) are not always straight under sniffing condition. Therefore, to make easy to insert a double-lumen tube and reduce the tube-related complications, we are trying to compare the individually angle-modified tube and the manufacturer-provided-angled tube.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-06
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-22
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Subjects undergoing thoracic surgery under one lung ventilation
• Subjects older than 20 yrs who can give written informed consent

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Exclusion Criteria

• Those who need rapid sequence intubation
• Those with cervical spinal disease (cervical spinal injury, rheumatoid arthritis with atlantoaxial subluxation)
• Those with oropharyngeal obstructive disease (including tumor, foreign body)
• Those who are expected prolonged intubation after surgery
• Those who are pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tube angle modification	Mallinckrodt endotracheal tube with a modified angle	The angle of the double lumen tube(MallinckrodeTM endotracheal tube) is modified individually.At sniffing position, the distal tip of the tube is placed at the patient's cricoid cartilage level and the tube is bent at the intersection point of the two airway axes (oropharyngeal axis and tracheal axis) with an angle between the two axes.
Control group	Mallinckrodt endobronchial tube with a conventional angle	Intubating a manufacturer-provided-angled double-lumen tube (=Conventional-angled group,"MallinckrodtTM endotracheal tube", Covidien)

Primary Outcome Measures

Name	Time	Method
The time taken to intubate a double-lumen tube	within 60 sec	The time taken to insert the tube begins when the laryngoscope passes the patient's lips and ends when the tube passes the vocal cords

Secondary Outcome Measures

Name	Time	Method
The number of attempts needed for successful intubation	Intubation
Postoperative sore throat, hoarseness or dysphagia	30 minutes and 24hours after extubation
The time taken for the first attempt of intubation	within 60 sec

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of