NCT01824914

Brief Summary

Difficult tracheal intubation is a cause of severe patient damage and death. There is not a good method to predict it. The McGrath Series 5 video laryngoscope can improve visualization of the glottic structures one to two grades. Moreover unlike a classical laryngoscope with a Macintosh blade, the McGrath provides a view of the glottis without requiring alignment of the oral, pharyngeal and laryngeal axes. In this study, the investigators will use it to compare the Cormack-Lehane score in sedation and anesthesia condition. It helps to know the role of videolaryngoscope in predicting difficult intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

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

First Submitted

Initial submission to the registry

March 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 7, 2014

Status Verified

November 1, 2014

Enrollment Period

6 months

First QC Date

March 25, 2013

Last Update Submit

November 6, 2014

Conditions

Keywords

videolaryngoscopetracheal intubationCormack-Lehane gradeairway evaluationsedationanesthesia

Outcome Measures

Primary Outcomes (2)

  • Cormack-Lehane score in sedation condition

    Based on the Modified Cormack-Lehane classification. 5 degrades. 1-5

    5 minutes after administration of sufentanil

  • Cormack-lehane score in anesthesia condition

    Based on the Modified Cormack-Lehane classification. 5 degrades. 1-5

    1 minute after administration of rocuronium

Secondary Outcomes (2)

  • Duration of intubation

    At intubation

  • Sedation score

    5 minutes after administraion of sufentanil

Other Outcomes (4)

  • BMI

    One day before operation

  • Thyromental distance

    One day before operation

  • Mallampati classification

    One day before operation

  • +1 more other outcomes

Study Arms (1)

McGrath Videolaryngoscope

EXPERIMENTAL

to compare the Cormack-Lehane grade in sedation and anesthesia by McGrath videolaryngoscope

Device: McGrath Videolaryngoscope

Interventions

A kind of portable videolaryngoscopes, produced by Aircraft Medical. It has been used for difficult airway.

McGrath Videolaryngoscope

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for general surgery under general anesthesia
  • ASA classification 1-3

You may not qualify if:

  • emergent operation, aspiration risk
  • a history of difficult airway
  • expected difficult airway
  • incooperative patients with mental diseases, hearing disorders

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

Study Officials

  • Yuke Tian, Ph.D.,M.D.

    Huazhong University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D., Attending physician

Study Record Dates

First Submitted

March 25, 2013

First Posted

April 5, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 7, 2014

Record last verified: 2014-11

Locations