NCT02190201

Brief Summary

The investigators previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. But it is not determined about the advantages and disadvantages of McGrath Series 5 videolaryngoscope for double-lumen tube intubation, compared with traditional Macintosh laryngoscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

4 months

First QC Date

July 10, 2014

Last Update Submit

November 19, 2014

Conditions

Intubation; DifficultThoracic DiseasesIntubation Complication

Keywords

videolaryngoscopedouble lumen intubation

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    measured with a stopwatch, defined as time from inserting blade to mouth to withdrawal of blade

    at intubation

Secondary Outcomes (1)

  • number of successful intubation at first attempt

    at intubation

Other Outcomes (1)

  • Airway evaluation with Cormack-Lehane Score

    At intubation

Study Arms (2)

videolaryngoscope

EXPERIMENTAL

DLT intubation with McGrath videolaryngoscope

Device: videolaryngoscope

Direct laryngoscope

ACTIVE COMPARATOR

DLT intubation with Macintosh laryngoscope

Device: Direct laryngoscope

Interventions

videolaryngoscopeDEVICE

a kind of videolaryngoscopes, which are widely used in difficult airways.

Also known as: McGrath series 5 videolaryngoscope
videolaryngoscope
Direct laryngoscopeDEVICE

A kind of traditional laryngoscopes

Also known as: Macintosh laryngoscopes
Direct laryngoscope

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients
  • Thoracic surgery required one lung ventilation

You may not qualify if:

  • Difficult ventilation
  • Emergent operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Yuke Tian, M.D.

    Huazhong University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 15, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 21, 2014

Record last verified: 2014-11

Locations

CN(1)