NCT03516539

Brief Summary

Video laryngoscopy provides easily a good laryngeal view compared to direct laryngoscopy. It is particularly, useful in patients with anticipated difficult intubation, and also widely used for educational purposes. Among video laryngoscopy, Mcgrath is a recently-developed, portable video laryngoscopy with a liquid crystal display (LCD) monitor and disposable curved blade. Mcgrath is known to provide excellent laryngeal visibility even in case of anticipated-difficult and anticipated-unsuccessful intubation as well as normal airway management. However, compared with direct laryngoscopy, the success rate of intubation and the time required for anticipated difficult intubation have been reported conflicting results in previous studies. The aim of this study was to compare the intubation success rate, the intubation time and the ease of use with Mcgrath video laryngoscopy and direct laryngoscopy during intubation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 11, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2018

Completed
Last Updated

May 4, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

April 24, 2018

Last Update Submit

April 24, 2018

Conditions

Keywords

Videolaryngoscopy

Outcome Measures

Primary Outcomes (1)

  • Intubation success rate

    success or failure of intubation

    1 hour

Secondary Outcomes (3)

  • Time required for intubation

    1 hour

  • Intubation difficulty score

    1 hour

  • Complications

    1 day

Study Arms (2)

Group ML

EXPERIMENTAL

Mcgrath videolaryngoscopy

Device: Group ML

Group DL

ACTIVE COMPARATOR

direct Macintosh laryngoscope

Device: Group DL

Interventions

Group MLDEVICE

Mcgrath videolaryngoscope

Group ML
Group DLDEVICE

Macintosh laryngoscope

Group DL

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for general anesthesia requiring tracheal intubation. Patients are aged 19 to 70 years and are American Society of Anesthesiologists physical status I, II.

You may not qualify if:

  • Patients requiring rapid sequence intubation Patients with poor teeth or high risk of aspiration pneumonia Cervical spine pathology, pharyngeal pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 14068, South Korea

RECRUITING

Related Publications (4)

  • Rai MR, Dering A, Verghese C. The Glidescope system: a clinical assessment of performance. Anaesthesia. 2005 Jan;60(1):60-4. doi: 10.1111/j.1365-2044.2004.04013.x.

    PMID: 15601274BACKGROUND
  • Asai T, Murao K, Shingu K. Training method of applying pressure on the neck for laryngoscopy: use of a videolaryngoscope. Anaesthesia. 2003 Jun;58(6):602-3. doi: 10.1046/j.1365-2044.2003.03207_7.x. No abstract available.

    PMID: 12846635BACKGROUND
  • Shippey B, Ray D, McKeown D. Case series: the McGrath videolaryngoscope--an initial clinical evaluation. Can J Anaesth. 2007 Apr;54(4):307-13. doi: 10.1007/BF03022777.

  • Shippey B, Ray D, McKeown D. Use of the McGrath videolaryngoscope in the management of difficult and failed tracheal intubation. Br J Anaesth. 2008 Jan;100(1):116-9. doi: 10.1093/bja/aem303. Epub 2007 Oct 23.

Study Officials

  • Yi Hwa Choi, Dr

    Halllym university Sacred Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 4, 2018

Study Start

December 11, 2017

Primary Completion

June 30, 2018

Study Completion

July 7, 2018

Last Updated

May 4, 2018

Record last verified: 2018-04

Locations