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

Intubation, Intratracheal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190032
• Other study ID #: 2014-06-003-004
• Status: Completed
• Phase: N/A
• First received: July 6, 2014
• Last updated: February 22, 2015
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Intubation, Intratracheal
• Thoracic Surgical Procedures

Intervention

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.
• Mallinckrodt endobronchial tube with a conventional angle
Inserting a manufacturer-provided conventional-angled tube

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Primary	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	No
Secondary	The number of attempts needed for successful intubation		Intubation	No
Secondary	The time taken for the first attempt of intubation		within 60 sec	No
Secondary	Postoperative sore throat, hoarseness or dysphagia		30 minutes and 24hours after extubation	No