Predictive Value of TestsNCT03647371
TMHT - Difficult Intubation Prediction Using Videolaryngoscopy
A study testing Macintosh laryngoscopy and McGrath MAC video laryngoscopy in people with Predictive Value of Tests and Intubation, 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 using videolaryngoscopy and double lumen endotracheal tubes in patients scheduled for elective thoracic procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Predictive Value of Tests, Intubation
- What is being tested?
- Macintosh laryngoscopy and McGrath MAC video laryngoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 6 Aug 2018to 5 Nov 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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 Videolaryngoscopy
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.
Read the detailed description
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
- Predictive Value of Tests, Intubation
- Being tested
- Macintosh laryngoscopy, McGrath MAC video laryngoscopy
- Keywords
- Difficult Intubation, Thyromental Height Test, Videolaryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh laryngoscopyProcedure or surgery
intubation with MAcintosh laryngoscopy after anesthetic induction
McGrath MAC video laryngoscopyProcedure or surgery
intubation with McGrath MAC videolaryngoscopy after anesthetic induction
| Study group | Role | What they receive |
|---|---|---|
| Macintosh laryngoscope | Other | direct laryngoscope - laryngoscope with Macintosh blade Receives: Procedure: Macintosh laryngoscopy |
| McGrath videolaryngoscope | Other | McGrath Videolaryngoscope Receives: Procedure: McGrath MAC video laryngoscopy |
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: From August 6 2018 to August 5 2019.
Secondary outcomes (5)
score in Cormack-Lehane scale
During videolaryngoscopy 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: From August 6 2018 to August 5 2019.
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: From August 6 2018 to August 5 2019.
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: From August 6 2018 to August 5 2019.
core 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: From August 6 2018 to August 5 2019.
distance of mouth opening
Measured as a distance between the lower and upper incisors with a tape measure (Standard, Hoechstmas, Sulzbach, Germany) as a distance in centimetres. Patients are in sitting position with mouth maximally opened, tongue retracted and without phonation.
Measured: From August 6 2018 to August 5 2019.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start6 Aug 2018
- Primary completion5 Nov 2019
- Study completion5 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 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
- NCT03647371
- Sponsor's protocol ID
- TMHT-03
- Status last verified
- Apr 2020
- First submitted
- 5 Aug 2018
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 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 Videolaryngoscopy
- ClinicalTrials.gov ID
- NCT03647371
- Acronym / sponsor ID
- TMHT-03
- Conditions
- Predictive Value of Tests, Intubation
- Keywords
- Difficult Intubation, Thyromental Height Test, Videolaryngoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 5 Nov 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 27 Aug 2018 (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 using videolaryngoscopy and double lumen endotracheal tubes in patients scheduled for elective thoracic procedures.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh laryngoscope | Other | Procedure: Macintosh laryngoscopydirect laryngoscope - laryngoscope with Macintosh blade |
| McGrath videolaryngoscope | Other | Procedure: McGrath MAC video laryngoscopyMcGrath Videolaryngoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Macintosh laryngoscopyintubation with MAcintosh laryngoscopy after anesthetic induction | Procedure or surgery | Macintosh laryngoscope |
| McGrath MAC video laryngoscopyintubation with McGrath MAC videolaryngoscopy after anesthetic induction | Procedure or surgery | McGrath videolaryngoscope |
Primary outcome
Thyromental height
Time frame: From August 6 2018 to August 5 2019.
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.
5 secondary outcomes
score in Cormack-Lehane scale
Time frame: From August 6 2018 to August 5 2019.
Thyromental distance
Time frame: From August 6 2018 to August 5 2019.
Sternomental distance
Time frame: From August 6 2018 to August 5 2019.
core in modified Mallampati test
Time frame: From August 6 2018 to August 5 2019.
distance of mouth opening
Time frame: From August 6 2018 to August 5 2019.
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 14 Apr 2020.
- Individual participant dataSharing planned: No
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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?
A study testing Macintosh laryngoscopy and McGrath MAC video laryngoscopy in people with Predictive Value of Tests and Intubation, 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 14 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: From August 6 2018 to August 5 2019.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2020.