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

Comparison of Individually Modified Angled Tube and Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Intubation, Intratracheal; Thoracic Surgical Procedures
• Intervention / Treatment: Device: Mallinckrodt endobronchial tube with a conventional angle; Device: Mallinckrodt endotracheal tube with a modified angle

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Intubating a manufacturer-provided-angled double-lumen tube (=Conventional-angled group,"MallinckrodtTM endotracheal tube", Covidien)	Device: Mallinckrodt endobronchial tube with a conventional angle; Inserting a manufacturer-provided conventional-angled tube; Other Names: Mallinckrodt endobronchial tube, Covidien, with conventional-angled tube
Experimental: Tube angle modification; 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.	Device: Mallinckrodt endotracheal tube with a modified angle; At sniffing position, the distal tip of a double-lumen tube is located at the patient's cricoid cartilage level and then the tube is bent at the intersection point of oral axis and the pharyngolaryngeal axis with an angle between the two axes.; Other Names: Tube angle modification; ("MallinckrodeTM endotracheal tube", Covidien)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time taken to intubate a double-lumen tube	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	within 60 sec

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic change	We will record patient's heart rate, blood pressure and any used cardiovascular drugs at 1, 3 and 5 min after intubation	1, 3 and 5 min after intubation
Intubation difficulty scale score	Intubation difficulty Scale score is a function of seven parameters : number of attempts, number of operators, number of alternative techniques, cormack grade, lifting force needed, laryngeal pressure and vocal cord mobility. (Ref: Intubation Difficulty Scale, Anesthesiology 1997;87:1290-7)	At intubation

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Jong Hwan Lee, MD,PhD, Samsung Medical Center

Publications and helpful links

General Publications

• Min JJ, Lee JH, Kang SH, Kim E, Lee SM, Cho JH, Kim HK. The Fast and Easy Way for Double-Lumen Tube Intubation: Individual Angle-Modification. PLoS One. 2016 Aug 18;11(8):e0161434. doi: 10.1371/journal.pone.0161434. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 6, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): February 24, 2015
• Last Update Submitted That Met QC Criteria: February 22, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 2014-06-003-004