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

NCT ID: NCT02190032

Last Updated: 2015-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Intubation, Intratracheal Thoracic Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

Intubating a manufacturer-provided-angled double-lumen tube (=Conventional-angled group,"MallinckrodtTM endotracheal tube", Covidien)

Group Type ACTIVE_COMPARATOR

Mallinckrodt endobronchial tube with a conventional angle

Intervention Type DEVICE

Inserting a manufacturer-provided conventional-angled tube

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.

Group Type EXPERIMENTAL

Mallinckrodt endotracheal tube with a modified angle

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Mallinckrodt endobronchial tube with a conventional angle

Inserting a manufacturer-provided conventional-angled tube

Intervention Type DEVICE

Other Intervention Names

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Tube angle modification ("MallinckrodeTM endotracheal tube", Covidien) Mallinckrodt endobronchial tube, Covidien, with conventional-angled tube

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong Hwan Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong Hwan Lee, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 27537372 (View on PubMed)

Other Identifiers

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2014-06-003-004

Identifier Type: -

Identifier Source: org_study_id

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