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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02190032
Enrollment
108
Registered
2014-07-15
Start date
2014-07-31
Completion date
2015-01-31
Last updated
2015-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation, Intratracheal, Thoracic Surgical Procedures

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.

Interventions

DEVICEMallinckrodt 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.

DEVICEMallinckrodt endobronchial tube with a conventional angle

Inserting a manufacturer-provided conventional-angled tube

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The time taken to intubate a double-lumen tubewithin 60 secThe 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

MeasureTime frame
The number of attempts needed for successful intubationIntubation
The time taken for the first attempt of intubationwithin 60 sec
Postoperative sore throat, hoarseness or dysphagia30 minutes and 24hours after extubation

Other

MeasureTime frameDescription
Intubation difficulty scale scoreAt intubationIntubation 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)
Hemodynamic change1, 3 and 5 min after intubationWe will record patient's heart rate, blood pressure and any used cardiovascular drugs at 1, 3 and 5 min after intubation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026