TMHT - Difficult Intubation Prediction Using Double Lumen Video Tubes

NCT ID: NCT04101734

Last Updated: 2020-04-28

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

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2019-10-01

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 and the utility of double lumen video endotracheal tubes in patients scheduled for elective thoracic procedures.

Detailed Description

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Most of the thoracic surgery interventions require lung isolation techniques. Currently the most commonly used lung isolation techniques are double lumen tubes or single lumen tubes with additional use of bronchial blockers. In both cases fiberoptic bronchoscopy is used for proper placement and maintenance during operation. Recently double lumen video endotracheal tubes were proposed as a new alternative for lung isolation techniques. The double lumen video endotracheal tube differs significantly in size and physical characteristics from standard single lumen endotracheal tube and intubation may prove to be challenging even for an experienced practitioner. Therefore proper prediction of difficult intubation play a crucial role in a clinical setting. Sensitivity and specificity of existing anthropometric scales and tests used for prediction of difficult intubation seem lacking so new methods such as Thyromental Height Test (TMHT) are being introduced. 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 double lumen video endotracheal tubes in patients scheduled for elective thoracic surgical procedures. The secondary aim is to evaluate the utility of double lumen video endotracheal tubes as a novel method of lung separation.

Conditions

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Predictive Value of Tests Intubation;Difficult

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Double Lumen Endotracheal Tube

Group of patients intubated with Double Lumen Endotracheal Tube.

Double Lumen Endotracheal Tube.

Intervention Type DEVICE

Intubation was performed with Double Lumen Endotracheal Tube.

Double Lumen Video Endotracheal Tube

Group of patients intubated with Double Lumen Video Endotracheal Tube.

Double Lumen Video Endotracheal Tube.

Intervention Type DEVICE

Intubation was performed with Double Lumen Video Endotracheal Tube.

Interventions

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Double Lumen Endotracheal Tube.

Intubation was performed with Double Lumen Endotracheal Tube.

Intervention Type DEVICE

Double Lumen Video Endotracheal Tube.

Intubation was performed with Double Lumen Video Endotracheal Tube.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients scheduled for elective thoracic procedures, requiring general anaesthesia and intubation with 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

Yes

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

References

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Palaczynski P, Misiolek H, Bialka S, Owczarek AJ, Gola W, Szarpak L, Smereka J. A randomized comparison between the VivaSight double-lumen tube and standard double-lumen tube intubation in thoracic surgery patients. J Thorac Dis. 2022 Oct;14(10):3903-3914. doi: 10.21037/jtd-22-451.

Reference Type DERIVED
PMID: 36389329 (View on PubMed)

Other Identifiers

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TMHT-04

Identifier Type: -

Identifier Source: org_study_id

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