Predictive Value of TestsNCT04101734
TMHT - Difficult Intubation Prediction Using Double Lumen Video Tubes
An observational study of Predictive Value of Tests and Intubation;Difficult, run by Medical University of Silesia at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Predictive Value of Tests, Intubation;Difficult
- What is being tested?
- Double Lumen Endotracheal Tube. and Double Lumen Video Endotracheal Tube.
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2019to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients undergoing elective thoracic procedures in university hospital, requiring general anaesthesia and intubation with a double lumen endotracheal tubes.
Who may be able to join
- 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
Who cannot join
- emergency procedures
- visible anatomic abnormalities
- patients scheduled for awake fibre optic intubation
- lack of consent for participation in the trail
Trial locations and contacts
1 site in 1 country.
Poland1 site
Samodzielny Publiczny Szpital Kliniczny nr 1
Zabrze, Silesian Voivodeship, 41-800
About this study
Official title: Thyromental Height Test as a New Method for Prediction of Difficult Intubation Using Double Lumen Video Tubes
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.
Read the detailed description
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
- Predictive Value of Tests, Intubation;Difficult
- Being tested
- Double Lumen Endotracheal Tube., Double Lumen Video Endotracheal Tube.
- Keywords
- Difficult Intubation, Thyromental Height Test, Double Lumen Video Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Lumen Endotracheal Tube.Device
Intubation was performed with Double Lumen Endotracheal Tube.
Double Lumen Video Endotracheal Tube.Device
Intubation was performed with Double Lumen Video Endotracheal Tube.
| Study group | Role | What they receive |
|---|---|---|
| Double Lumen Endotracheal Tube | Group of patients intubated with Double Lumen Endotracheal Tube. Receives: Device: Double Lumen Endotracheal Tube. | |
| Double Lumen Video Endotracheal Tube | Group of patients intubated with Double Lumen Video Endotracheal Tube. Receives: Device: Double Lumen Video Endotracheal Tube. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative (1 day prior to the operation)
Secondary outcomes (7)
Time of Intubation
Time of intubation defined as a time from direct laryngoscopy to proper placement of double lumen endotracheal tube measured with a timer during induction of general anesthesia.
Measured: Intraoperatively
Airway trauma
During fiberoptic bronchoscopy after the operation airway trauma on the level of bronchus, tracheal bifurcation, trachea and vocal cords were reported, where 0 was defined as no visible trauma, 1 as a redness, 2 as oedema, 3 as hematoma and 4 as active bleeding.
Measured: Intraoperative
Usage of fiberoptic bronchoscopy
Usage of fiberoptic bronchoscopy for proper placement of double lumen tube was noted.
Measured: Intraoperatively
score in Cormack-Lehane scale
During direct laryngoscopy the laryngeal view is graded in Cormack-Lehane Scale by the laryngoscopist. Grade I is assigned when the glottis is fully visible, grade II when the glottis is partially visible, grade III when only the epiglottis is visible and grade IV when neither glottis nor epiglottis is visible.
Measured: Preoperative (1 day prior to the operation)
Thyromental distance
The distance between the thyroid prominence and the most anterior part of the mental prominence of the mandible, measured with a standard centigrade ruler as the distance in centimetres with the patient in supine position, head fully extended, mouth closed, during routine preoperative anaesthetic visit.
Measured: Preoperative (1 day prior to the operation)
Sternomental distance
The distance in centimetres between the superior border of the manubrium sterni and the bony point of the mentum, with the patient in supine position, head fully extended, mouth closed, measured with a standard centigrade ruler, during routine preoperative anaesthetic visit.
Measured: Preoperative (1 day prior to the operation)
score in modified Mallampati test
The oropharyngeal view is assessed in sitting position, mouth maximally opened, tongue protruded, without phonation, measured during routine preoperative anaesthetic visit.
Measured: Preoperative (1 day prior to the operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Jun 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Predictive Value of TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Palaczyński, Medical University of Silesia
- Investigators
- Hanna Misiołek, MD PhD, Study director, Medical University of SilesiaSzymon Białka, MD, Study chair, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101734
- Sponsor's protocol ID
- TMHT-04
- Status last verified
- Apr 2020
- First submitted
- 22 Sep 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36389329
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyromental Height Test as a New Method for Prediction of Difficult Intubation Using Double Lumen Video Tubes
- ClinicalTrials.gov ID
- NCT04101734
- Acronym / sponsor ID
- TMHT-04
- Conditions
- Predictive Value of Tests, Intubation;Difficult
- Keywords
- Difficult Intubation, Thyromental Height Test, Double Lumen Video Tube
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double Lumen Endotracheal Tube | – | Device: Double Lumen Endotracheal Tube.Group of patients intubated with Double Lumen Endotracheal Tube. |
| Double Lumen Video Endotracheal Tube | – | Device: Double Lumen Video Endotracheal Tube.Group of patients intubated with Double Lumen Video Endotracheal Tube. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing elective thoracic procedures in university hospital, requiring general anaesthesia and intubation with a double lumen endotracheal tubes.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- emergency procedures
- visible anatomic abnormalities
- patients scheduled for awake fibre optic intubation
- lack of consent for participation in the trail
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double Lumen Endotracheal Tube.Intubation was performed with Double Lumen Endotracheal Tube. | Device | Double Lumen Endotracheal Tube |
| Double Lumen Video Endotracheal Tube.Intubation was performed with Double Lumen Video Endotracheal Tube. | Device | Double Lumen Video Endotracheal Tube |
Primary outcome
Thyromental height
Time frame: Preoperative (1 day prior to the operation)
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.
7 secondary outcomes
Time of Intubation
Time frame: Intraoperatively
Airway trauma
Time frame: Intraoperative
Usage of fiberoptic bronchoscopy
Time frame: Intraoperatively
score in Cormack-Lehane scale
Time frame: Preoperative (1 day prior to the operation)
Thyromental distance
Time frame: Preoperative (1 day prior to the operation)
Sternomental distance
Time frame: Preoperative (1 day prior to the operation)
score in modified Mallampati test
Time frame: Preoperative (1 day prior to the operation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Derived from this study: PubMed 36389329Palaczynski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanna Misiołek, MD PhD study director
Medical University of Silesia
Szymon Białka, MD study chair
Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Predictive Value of Tests and Intubation;Difficult, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyromental height (time frame: Preoperative (1 day prior to the operation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04101734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.