TMHT - Difficult Intubation Prediction Using Double Lumen Video Tubes

NCT04101734 | Completed

• 1 other identifier: TMHT-04
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Predictive Value of Tests; Intubation;Difficult

Keywords

Difficult Intubation; Thyromental Height Test; Double Lumen Video Tube

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.

  Preoperative (1 day prior to the operation)

Secondary Outcomes (7)

• Time of Intubation

  Intraoperatively

• Airway trauma

  Intraoperative

• Usage of fiberoptic bronchoscopy

  Intraoperatively

• score in Cormack-Lehane scale

  Preoperative (1 day prior to the operation)

• Thyromental distance

  Preoperative (1 day prior to the operation)

Study Arms (2)

Double Lumen Endotracheal Tube

Group of patients intubated with Double Lumen Endotracheal Tube.

Device: Double Lumen Endotracheal Tube.

Double Lumen Video Endotracheal Tube

Group of patients intubated with Double Lumen Video Endotracheal Tube.

Device: Double Lumen Video Endotracheal Tube.

Interventions

Double Lumen Endotracheal Tube. DEVICE

Intubation was performed with Double Lumen Endotracheal Tube.

Double Lumen Endotracheal Tube

Double Lumen Video Endotracheal Tube. DEVICE

Intubation was performed with Double Lumen Video Endotracheal Tube.

Double Lumen Video Endotracheal Tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

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

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Samodzielny Publiczny Szpital Kliniczny nr 1

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

Related Publications (1)

• 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.

  PMID: 36389329 DERIVED

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: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: September 24, 2019
• Study Start: June 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

PL (1)