TMHT - Difficult Intubation Prediction Using Videolaryngoscopy

NCT ID: NCT03647371

Last Updated: 2020-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-06

Study Completion Date

2019-11-05

Brief Summary

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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.

Detailed Description

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Successful and fast intubation are crucial for the safety of general anaesthesia. Failed intubation and acute hypoxia remain among the major contributing factors of anaesthesia related deaths. Difficult intubation prevalence in literature is very inconsistent and varies between 1.5-20% of cases in general population, to even 50% in obese Thai population.

There is a number of anthropometric scales and tests used for predicting difficult intubation. However, none of them appears to be sensitive and specific enough to effectively predict difficult intubation.

Recently, simple and non-invasive test predicting difficult intubation was introduced-thyromental height test (TMHT). It shows promise as a more effective substitution for frequently cited anthropometric measures. It is based on the height between the anterior border of the thyroid cartilage and the anterior border of the mentum, measured while the patient lies in the supine position with closed mouth The main objective of the trial is to assess the clinical usefulness of TMHT in prediction of difficult intubation using videolaryngoscopy and double lumen endotracheal tubes in patients scheduled for elective thoracic surgical procedures. The secondary aim is to evaluate usefulness of other commonly used predictive tests associated with difficult intubation.

During routine, preoperative anaesthetic visit thyromental height, thyromental distance, sternomental distance and Mallampati scale score are assessed. Then, during videolaryngoscopy and intubation, score in Cormack-Lehane scale and occurrence of difficult intubation are noted.

Conditions

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Predictive Value of Tests Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Macintosh laryngoscope

direct laryngoscope - laryngoscope with Macintosh blade

Group Type OTHER

Macintosh laryngoscopy

Intervention Type PROCEDURE

intubation with MAcintosh laryngoscopy after anesthetic induction

McGrath videolaryngoscope

McGrath Videolaryngoscope

Group Type OTHER

McGrath MAC video laryngoscopy

Intervention Type PROCEDURE

intubation with McGrath MAC videolaryngoscopy after anesthetic induction

Interventions

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Macintosh laryngoscopy

intubation with MAcintosh laryngoscopy after anesthetic induction

Intervention Type PROCEDURE

McGrath MAC video laryngoscopy

intubation with McGrath MAC videolaryngoscopy after anesthetic induction

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* emergency procedures
* visible anatomic abnormalities
* patients scheduled for awake fibre optic intubation
* lack of consent for participation in the trail
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Silesia

OTHER

Sponsor Role lead

Responsible Party

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Piotr Palaczyński

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanna Misiołek, MD PhD

Role: STUDY_DIRECTOR

Medical University of Silesia

Szymon Białka, MD

Role: STUDY_CHAIR

Medical University of Silesia

Locations

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Samodzielny Publiczny Szpital Kliniczny nr 1

Zabrze, Silesian Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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TMHT-03

Identifier Type: -

Identifier Source: org_study_id

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