NCT02190032

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 24, 2015

Status Verified

February 1, 2015

Enrollment Period

6 months

First QC Date

July 6, 2014

Last Update Submit

February 22, 2015

Conditions

Intubation, IntratrachealThoracic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 Outcomes (2)

  • Hemodynamic change

    1, 3 and 5 min after intubation

  • Intubation difficulty scale score

    At intubation

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Device: Mallinckrodt endobronchial tube with a conventional angle

Tube angle modification

EXPERIMENTAL

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

Interventions

Mallinckrodt endotracheal tube with a modified angleDEVICE

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.

Also known as: Tube angle modification, ("MallinckrodeTM endotracheal tube", Covidien)
Tube angle modification
Mallinckrodt endobronchial tube with a conventional angleDEVICE

Inserting a manufacturer-provided conventional-angled tube

Also known as: Mallinckrodt endobronchial tube, Covidien, with conventional-angled tube
Control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 27537372DERIVED

Study Officials

  • Jong Hwan Lee, MD,PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 6, 2014

First Posted

July 15, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 24, 2015

Record last verified: 2015-02

Locations

KR(1)