Difficult IntubationNCT04289597
Evaluation of Difficult Airway With Ultrasonography
An observational study of Difficult Intubation and Obesity, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
As a result of anatomical and physiological changes in obese patients, airway management can be challenging. Ultrasound measurement of neck anterior soft tissues combined with recommended predictive tests may increase the ability to predict the difficult airway. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Intubation, Obesity
- What is being tested?
- Distance between hyoid bone-skin (DSHB), Vocal cord anterior commissura-skin distance (DSAC) and minimum distance of the trachea to the skin at the level of suprasternal notch
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2020to 11 Mar 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A hundred twenty-eight patients, aged 18-65 years-old, with an American Anesthesiology Association physical classification (ASA) I-III and body mass index (BMI) above 30 and planned to undergo general anesthesia for elective surgery, will be included in the study.
Who may be able to join
- Patients planned to undergo general anesthesia for elective surgery
- American Anesthesiology Association physical classification (ASA) status I-III
- Body mass index (BMI) above 30
Who cannot join
- Patients with neck mass
- History of previous neck and thyroid surgery, trauma, arthritis, loss of teeth
- History of difficult intubation
- Bearded patients
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi Univercty
Odunpazari, Eskişehir, 26040
About this study
Official title: Evaluation of Difficult Airway in Obese Patients With Ultrasonography
As a result of anatomical and physiological changes in obese patients, airway management can be challenging. Ultrasound measurement of neck anterior soft tissues combined with recommended predictive tests may increase the ability to predict the difficult airway. In this study we planned to evaluate the measurement of neck anterior soft tissues by ultrasound in obese patients before anesthesia induction to anticipate difficult mask ventilation, difficult laryngoscopy, and intubation.
Read the detailed description
Patients with BMI> 30, schedule elective surgery under general anesthesia, and give consent will be included in the study. In the preoperative evaluation, demographic data of the patients, airway physical examination results (mouth opening, Mallampati score, thyromental distance, neck circumference (from thyroid cartilage level), abnormal upper tooth presence, neck movement restriction], presence of sleep apnea and STOP-BANG score will be recorded. In the patients taken on the operation table with supine position, ultrasound-guided soft tissue distances will be measured using ultrasound 6-13 Hz linear probe. The distance between the hyoid bone-skin (DSHB), the vocal cord anterior commissura-skin distance (DSAC), the minimum distance of the trachea to the skin at the level of the suprasternal notch (DST), the distance between the thyroid isthmus and the skin (DSI), and the distance between the epiglottis and the skin (DSE) will be measured and recorded. After standard monitoring and anesthesia induction, difficult mask ventilation will be evaluated with Han Scale [(1) can be ventilated with a mask; 2) can be ventilated with the airway (with or without muscle relaxation); 3) difficult mask ventilation (insufficient, unstable, two practitioners are needed); 4) cannot be ventilated by mask] and grade 3-4 will be recorded as difficult mask ventilation. Difficult laryngoscopy will be evaluated with Cormack Lehane Scale [grade 1: vocal cords appear; grade-2: posterior commissura and epiglottis visible; grade-3: only epiglottis are seen; grade-4: glottic structures are not visible] and grade 3-4 will be recorded as difficult laryngoscopy. Difficult intubation will also be evaluated with the number and duration of intubation attempts with the Macintosh blade. Tracheal intubation will be performed by an anesthesiologist who has at least two years of experience and unaware of ultrasound measurements. The duration of intubation (the time from the first handling of the laryngoscope until the capnography trace appeared) and the number of trials will be recorded.
- Conditions
- Difficult Intubation, Obesity
- Being tested
- Distance between hyoid bone-skin (DSHB), Vocal cord anterior commissura-skin distance (DSAC), minimum distance of the trachea to the skin at the level of suprasternal notch, Thyroid isthmus-skin distance (DSI), Skin-epiglottic distance (DSE)
- Keywords
- Difficult mask, Difficult laryngoscopy, Difficult intubation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distance between hyoid bone-skin (DSHB)Diagnostic test
Also called DSHB
Distance between hyoid bone-skin
Vocal cord anterior commissura-skin distance (DSAC)Diagnostic test
Also called DSAC
Vocal cord anterior commissura-skin distance
minimum distance of the trachea to the skin at the level of suprasternal notchDiagnostic test
Also called DST
Distance of the trachea to the skin at the level of suprasternal notch
Thyroid isthmus-skin distance (DSI)Diagnostic test
Also called DSI
Thyroid isthmus-skin distance
Skin-epiglottic distance (DSE)Diagnostic test
Also called DSE
Skin-epiglottic distance
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Obese patients with BMI>30 Receives: Diagnostic Test: Distance between hyoid bone-skin (DSHB); Diagnostic Test: Vocal cord anterior commissura-skin distance (DSAC); Diagnostic Test: minimum distance of the trachea to the skin at the level of suprasternal notch; Diagnostic Test: Thyroid isthmus-skin distance (DSI); Diagnostic Test: Skin-epiglottic distance (DSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficult Mask Ventilation
Difficult mask ventilation will be evaluated with Han scale [(1) can be ventilated with a mask; 2) can be ventilated with the airway (with or without muscle relaxation); 3) difficult mask ventilation (insufficient, unstable, two practitioners are needed); 4) cannot be ventilated by mask] and grade 3-4 will be recorded as difficult mask ventilation.
Measured: ''1 minute'' (During anesthesia induction)
Secondary outcomes (3)
Difficult laryngoscopy
Difficult laryngoscopy will be evaluated Cormack Lehane Scale [grade 1: vocal cords appear; grade-2: posterior commissura and epiglottis visible; grade-3: only epiglottis are seen; grade-4: glottic structures are not visible] and grade 3-4 will be recorded as difficult laryngoscopy.
Measured: ''1 minute''
Difficult intubation
Total number of intubation attempts
Measured: ''1 minute''
The duration of endotracheal intubation time
The time from the first handling of the laryngoscope until the capnography trace appeared
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start20 Aug 2020
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Difficult IntubationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Onay, Eskisehir Osmangazi University
- Investigators
- Meryem Onay, MD, Principal investigator, Teaching Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289597
- Sponsor's protocol ID
- ESOGU
- Status last verified
- Mar 2022
- First submitted
- 27 Feb 2020
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 2014 Nov 18;20:2343-50. doi: 10.12659/MSM.891037.
PubMed 25403231Ezri T, Gewurtz G, Sessler DI, Medalion B, Szmuk P, Hagberg C, Susmallian S. Prediction of difficult laryngoscopy in obese patients by ultrasound quantification of anterior neck soft tissue. Anaesthesia. 2003 Nov;58(11):1111-4. doi: 10.1046/j.1365-2044.2003.03412.x.
PubMed 14616599Liang H, Hou Y, Wei H, Feng Y. Supraglottic jet oxygenation and ventilation assisted fiberoptic intubation in a paralyzed patient with morbid obesity and obstructive sleep apnea: a case report. BMC Anesthesiol. 2019 Mar 20;19(1):40. doi: 10.1186/s12871-019-0709-7.
PubMed 30894124Murphy C, Wong DT. Airway management and oxygenation in obese patients. Can J Anaesth. 2013 Sep;60(9):929-45. doi: 10.1007/s12630-013-9991-x. Epub 2013 Jul 9.
PubMed 23836064Lundstrom LH, Moller AM, Rosenstock C, Astrup G, Wetterslev J. High body mass index is a weak predictor for difficult and failed tracheal intubation: a cohort study of 91,332 consecutive patients scheduled for direct laryngoscopy registered in the Danish Anesthesia Database. Anesthesiology. 2009 Feb;110(2):266-74. doi: 10.1097/ALN.0b013e318194cac8.
PubMed 19194154Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. Epub 2012 Mar 8.
PubMed 22401881Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989.
PubMed 31742568
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Difficult Airway in Obese Patients With Ultrasonography
- ClinicalTrials.gov ID
- NCT04289597
- Acronym / sponsor ID
- ESOGU
- Conditions
- Difficult Intubation, Obesity
- Keywords
- Difficult mask, Difficult laryngoscopy, Difficult intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 28 Feb 2020 (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.
As a result of anatomical and physiological changes in obese patients, airway management can be challenging. Ultrasound measurement of neck anterior soft tissues combined with recommended predictive tests may increase the ability to predict the difficult airway. In this study we planned to evaluate the measurement of neck anterior soft tissues by ultrasound in obese patients before anesthesia induction to anticipate difficult mask ventilation, difficult laryngoscopy, and intubation.
Detailed description
Patients with BMI> 30, schedule elective surgery under general anesthesia, and give consent will be included in the study. In the preoperative evaluation, demographic data of the patients, airway physical examination results (mouth opening, Mallampati score, thyromental distance, neck circumference (from thyroid cartilage level), abnormal upper tooth presence, neck movement restriction], presence of sleep apnea and STOP-BANG score will be recorded. In the patients taken on the operation table with supine position, ultrasound-guided soft tissue distances will be measured using ultrasound 6-13 Hz linear probe. The distance between the hyoid bone-skin (DSHB), the vocal cord anterior commissura-skin distance (DSAC), the minimum distance of the trachea to the skin at the level of the suprasternal notch (DST), the distance between the thyroid isthmus and the skin (DSI), and the distance between the epiglottis and the skin (DSE) will be measured and recorded. After standard monitoring and anesthesia induction, difficult mask ventilation will be evaluated with Han Scale [(1) can be ventilated with a mask; 2) can be ventilated with the airway (with or without muscle relaxation); 3) difficult mask ventilation (insufficient, unstable, two practitioners are needed); 4) cannot be ventilated by mask] and grade 3-4 will be recorded as difficult mask ventilation. Difficult laryngoscopy will be evaluated with Cormack Lehane Scale [grade 1: vocal cords appear; grade-2: posterior commissura and epiglottis visible; grade-3: only epiglottis are seen; grade-4: glottic structures are not visible] and grade 3-4 will be recorded as difficult laryngoscopy. Difficult intubation will also be evaluated with the number and duration of intubation attempts with the Macintosh blade. Tracheal intubation will be performed by an anesthesiologist who has at least two years of experience and unaware of ultrasound measurements. The duration of intubation (the time from the first handling of the laryngoscope until the capnography trace appeared) and the number of trials will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients | – | Diagnostic Test: Distance between hyoid bone-skin (DSHB), Diagnostic Test: Vocal cord anterior commissura-skin distance (DSAC), Diagnostic Test: minimum distance of the trachea to the skin at the level of suprasternal notch, Diagnostic Test: Thyroid isthmus-skin distance (DSI), Diagnostic Test: Skin-epiglottic distance (DSE)Obese patients with BMI>30 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A hundred twenty-eight patients, aged 18-65 years-old, with an American Anesthesiology Association physical classification (ASA) I-III and body mass index (BMI) above 30 and planned to undergo general anesthesia for elective surgery, will be included in the study.
Key inclusion criteria (3 listed)
- Patients planned to undergo general anesthesia for elective surgery
- American Anesthesiology Association physical classification (ASA) status I-III
- Body mass index (BMI) above 30
Key exclusion criteria (5 listed)
- Patients with neck mass
- History of previous neck and thyroid surgery, trauma, arthritis, loss of teeth
- History of difficult intubation
- Bearded patients
- Pregnant women
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 |
|---|---|---|
| Distance between hyoid bone-skin (DSHB)Also: DSHBDistance between hyoid bone-skin | Diagnostic test | Obese patients |
| Vocal cord anterior commissura-skin distance (DSAC)Also: DSACVocal cord anterior commissura-skin distance | Diagnostic test | Obese patients |
| minimum distance of the trachea to the skin at the level of suprasternal notchAlso: DSTDistance of the trachea to the skin at the level of suprasternal notch | Diagnostic test | Obese patients |
| Thyroid isthmus-skin distance (DSI)Also: DSIThyroid isthmus-skin distance | Diagnostic test | Obese patients |
| Skin-epiglottic distance (DSE)Also: DSESkin-epiglottic distance | Diagnostic test | Obese patients |
Primary outcome
Difficult Mask Ventilation
Time frame: ''1 minute'' (During anesthesia induction)
Difficult mask ventilation will be evaluated with Han scale [(1) can be ventilated with a mask; 2) can be ventilated with the airway (with or without muscle relaxation); 3) difficult mask ventilation (insufficient, unstable, two practitioners are needed); 4) cannot be ventilated by mask] and grade 3-4 will be recorded as difficult mask ventilation.
3 secondary outcomes
Difficult laryngoscopy
Time frame: ''1 minute''
Difficult intubation
Time frame: ''1 minute''
The duration of endotracheal intubation time
Time frame: 1 minute
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 Mar 2022.
- Background: PubMed 25403231Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 2014 Nov 18;20:2343-50. doi: 10.12659/MSM.891037.
- Background: PubMed 14616599Ezri T, Gewurtz G, Sessler DI, Medalion B, Szmuk P, Hagberg C, Susmallian S. Prediction of difficult laryngoscopy in obese patients by ultrasound quantification of anterior neck soft tissue. Anaesthesia. 2003 Nov;58(11):1111-4. doi: 10.1046/j.1365-2044.2003.03412.x.
- Background: PubMed 30894124Liang H, Hou Y, Wei H, Feng Y. Supraglottic jet oxygenation and ventilation assisted fiberoptic intubation in a paralyzed patient with morbid obesity and obstructive sleep apnea: a case report. BMC Anesthesiol. 2019 Mar 20;19(1):40. doi: 10.1186/s12871-019-0709-7.
- Background: PubMed 23836064Murphy C, Wong DT. Airway management and oxygenation in obese patients. Can J Anaesth. 2013 Sep;60(9):929-45. doi: 10.1007/s12630-013-9991-x. Epub 2013 Jul 9.
- Background: PubMed 19194154Lundstrom LH, Moller AM, Rosenstock C, Astrup G, Wetterslev J. High body mass index is a weak predictor for difficult and failed tracheal intubation: a cohort study of 91,332 consecutive patients scheduled for direct laryngoscopy registered in the Danish Anesthesia Database. Anesthesiology. 2009 Feb;110(2):266-74. doi: 10.1097/ALN.0b013e318194cac8.
- Background: PubMed 22401881Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. Epub 2012 Mar 8.
- Background: PubMed 31742568Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989.
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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.
Meryem Onay, MD principal investigator
Teaching Assistant
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 Intubation and Obesity, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 5 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 Mar 2022. 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 Turkey (Türkiye). 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?
Difficult Mask Ventilation (time frame: ''1 minute'' (During anesthesia induction)). 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 NCT04289597, which also lists 7 linked publications.
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 Mar 2022.