NCT02988336

Brief Summary

The purpose of this study is to assess the usefulness of the Thyromental Height Test in prediction of difficult intubation using 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
237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

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

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

November 30, 2016

Last Update Submit

January 29, 2017

Conditions

Keywords

difficult intubationthyromental height

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, measured during routine preoperative anaesthetic visit.

    immediate

Secondary Outcomes (4)

  • Thyromental distance

    immediate

  • Sternomental distance

    immediate

  • score in modified Mallampati test

    immediate

  • score in Cormack-Lehane scale

    immediate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients undergoing elective thoracic procedures in university hospital, requiring general anaesthesia, elective direct laryngoscopy and intubation with a double lumen endotracheal tubes.

You may qualify if:

  • patients scheduled for elective thoracic procedures, requiring general anaesthesia, direct laryngoscopy and intubation with a Robertshaw type double lumen endotracheal tubes
  • consent for participation in the trail
  • older than 18

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

Related Publications (1)

  • Palczynski P, Bialka S, Misiolek H, Copik M, Smelik A, Szarpak L, Ruetzler K. Thyromental height test as a new method for prediction of difficult intubation with double lumen tube. PLoS One. 2018 Sep 13;13(9):e0201944. doi: 10.1371/journal.pone.0201944. eCollection 2018.

Study Officials

  • Hanna Misiołek, MD PhD

    School of Medicine with the Division of Dentistry in Zabrze. Medical University of Silesia. Department of Anaesthesiology and Critical Care.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 9, 2016

Study Start

September 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 31, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations