NCT03647371

Brief Summary

The purpose of this study is to assess the usefulness of the Thyromental Height Test in prediction of difficult intubation using videolaryngoscopy and double lumen endotracheal tubes in patients scheduled for elective thoracic procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

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

August 5, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 6, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2019

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

1.2 years

First QC Date

August 5, 2018

Last Update Submit

April 12, 2020

Conditions

Keywords

Difficult IntubationThyromental Height TestVideolaryngoscopy

Outcome Measures

Primary Outcomes (1)

  • Thyromental height

    The height between the anterior border of the thyroid cartilage (on the thyroid notch just between the 2 thyroid laminae) and the anterior border of the mentum (on the mental protuberance of the mandible), in supine position with mouth closed, measured with a depth gauge during routine preoperative anaesthetic visit.

    From August 6 2018 to August 5 2019.

Secondary Outcomes (5)

  • score in Cormack-Lehane scale

    From August 6 2018 to August 5 2019.

  • Thyromental distance

    From August 6 2018 to August 5 2019.

  • Sternomental distance

    From August 6 2018 to August 5 2019.

  • core in modified Mallampati test

    From August 6 2018 to August 5 2019.

  • distance of mouth opening

    From August 6 2018 to August 5 2019.

Study Arms (2)

Macintosh laryngoscope

OTHER

direct laryngoscope - laryngoscope with Macintosh blade

Procedure: Macintosh laryngoscopy

McGrath videolaryngoscope

OTHER

McGrath Videolaryngoscope

Procedure: McGrath MAC video laryngoscopy

Interventions

intubation with MAcintosh laryngoscopy after anesthetic induction

Macintosh laryngoscope

intubation with McGrath MAC videolaryngoscopy after anesthetic induction

McGrath videolaryngoscope

Eligibility Criteria

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

You may qualify if:

  • patients scheduled for elective thoracic procedures, requiring general anaesthesia, videolaryngoscopy and intubation with a Robert-Shaw type double lumen endotracheal tubes
  • written, informed consent for participation in the trail
  • older than 18 years

You may not qualify if:

  • emergency procedures
  • visible anatomic abnormalities
  • patients scheduled for awake fibre optic intubation
  • lack of consent for participation in the trail

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samodzielny Publiczny Szpital Kliniczny nr 1

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

Study Officials

  • Hanna Misiołek, MD PhD

    Medical University of Silesia

    STUDY DIRECTOR
  • Szymon Białka, MD

    Medical University of Silesia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2018

First Posted

August 27, 2018

Study Start

August 6, 2018

Primary Completion

November 5, 2019

Study Completion

November 5, 2019

Last Updated

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations