Difficult Airway IntubationNCT04212156
Thyromental Height Test (TMHT) as a Predictor of Difficult Airway in Obese Patients
An observational study of Difficult Airway Intubation, run by Cairo University at 1 site in Egypt.
Trial summary
Difficult airway management is a major concern for anesthetists and contributes to perioperative morbidity and mortality. The incidence of difficult intubation in the obese population with a BMI of greater than 30 has been reported to be 15.8%. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Difficult Airway Intubation
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2020to 20 Jan 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients of both sex, aged between 18-60 years old, ASA physical status II\& III with BMI > 30 Kg/m2 who will undergo elective surgical procedures under general anesthesia using endotracheal intubation using conventional laryngoscopy
Who may be able to join
- Patients aged between 18-60 years old, ASA physical status II\& III with BMI > 30 Kg/m2 who will undergo elective surgical procedures under general anesthesia using endotracheal intubation with conventional laryngoscopy
Who cannot join
- Patients with neuromuscular disorders, craniofacial abnormalities, abnormal dentition, uncooperative, who need awake intubation and patients who undergoing emergency operations will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity of Thyromental Height Test (TMHT) as an Objective Predictor of Difficult Airway in Obese Patients: a Prospective Observational Cohort Study
Difficult airway management is a major concern for anesthetists and contributes to perioperative morbidity and mortality. The incidence of difficult intubation in the obese population with a BMI of greater than 30 has been reported to be 15.8%. Thyromental height test (TMHT) is a new bedside test for difficult airway, it is a measure of the height between the anterior borders of the mentum and thyroid cartilage. TMHT can act as a surrogate for amount of mandibular protrusion; dimensions of submandibular space; and anterior position of the larynx. It appears promising as a single anatomical measure to predict the risk of difficult laryngoscopy.
- Conditions
- Difficult Airway Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TMH test | Patient will be asked to lay supine while the head and neck maintained in a neutral position using a pillow under the head. By using digital depth gauge, the TMH will be measured from the anterior border of the thyroid cartilage directly on the thyroid notch till the anterior border of the mentum |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMHT
Validity of TMHT for prediction of difficult airway in obese patient undergoing general anesthesia
Measured: before induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start20 Jan 2020
- Primary completion20 Jan 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Airway IntubationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Ahmed, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212156
- Sponsor's protocol ID
- Ms-266-2019
- Status last verified
- May 2021
- First submitted
- 23 Dec 2019
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Thyromental Height Test (TMHT) as an Objective Predictor of Difficult Airway in Obese Patients: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04212156
- Acronym / sponsor ID
- Ms-266-2019
- Conditions
- Difficult Airway Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 26 Dec 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.
Difficult airway management is a major concern for anesthetists and contributes to perioperative morbidity and mortality. The incidence of difficult intubation in the obese population with a BMI of greater than 30 has been reported to be 15.8%. Thyromental height test (TMHT) is a new bedside test for difficult airway, it is a measure of the height between the anterior borders of the mentum and thyroid cartilage. TMHT can act as a surrogate for amount of mandibular protrusion; dimensions of submandibular space; and anterior position of the larynx. It appears promising as a single anatomical measure to predict the risk of difficult laryngoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMH test | – | –Patient will be asked to lay supine while the head and neck maintained in a neutral position using a pillow under the head. By using digital depth gauge, the TMH will be measured from the anterior border of the thyroid cartilage directly on the thyroid notch till the anterior border of the mentum |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients of both sex, aged between 18-60 years old, ASA physical status II\& III with BMI > 30 Kg/m2 who will undergo elective surgical procedures under general anesthesia using endotracheal intubation using conventional laryngoscopy
Key inclusion criteria (1 listed)
- Patients aged between 18-60 years old, ASA physical status II\& III with BMI > 30 Kg/m2 who will undergo elective surgical procedures under general anesthesia using endotracheal intubation with conventional laryngoscopy
Key exclusion criteria (1 listed)
- Patients with neuromuscular disorders, craniofacial abnormalities, abnormal dentition, uncooperative, who need awake intubation and patients who undergoing emergency operations will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
TMHT
Time frame: before induction of general anesthesia
Validity of TMHT for prediction of difficult airway in obese patient undergoing general anesthesia
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 17 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Difficult Airway Intubation, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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 17 May 2021. 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 Egypt. 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?
TMHT (time frame: before induction of general anesthesia). 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 17 May 2021.