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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02190032
Other study ID # 2014-06-003-004
Secondary ID
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)


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
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