Difficult Airway IntubationintubationNCT04712227
Can the Ratio of Chin-neck Circumference and Neck Circumference to Chin-neck Circumference Predict Difficult Intubation in Obese Patients?
An observational study of Difficult Airway Intubation and Obesity Adult Onset, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Importance and Purpose of the Study: Proper management of the difficult airway is an important part of preventing anesthesia-related mortality and morbidity. Difficult airways, characterized by both difficult mask ventilation and difficult intubation, are common in obese patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Difficult Airway Intubation, Obesity Adult Onset
- What is being tested?
- intubation and mask ventilation
- How many people
- 4 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Sep 2019to 7 Jun 2020
- How long will I take part?
- 6 Months
- 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: Patients who will be operated under general anesthesia with endotracheal intubation, aged 18 years and over, with body mass index (BMI≥30) and ASA 1-3
Inclusion Criteria: Patients who will be operated under general anesthesia with endotracheal intubation, aged 18 years and over, with body mass index (BMI≥30) and ASA 1-3
Exclusion Criteria:Patients with cervical spine anomalies, emergency procedures, known difficult intubation history and awake intubation plan, and those with beard were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Keçiören training and research hospital
Ankara, 06000
About this study
Importance and Purpose of the Study: Proper management of the difficult airway is an important part of preventing anesthesia-related mortality and morbidity. Difficult airways, characterized by both difficult mask ventilation and difficult intubation, are common in obese patients. Many studies have shown an association between obesity or morbid obesity and difficult intubation. We thought that in obese patients, increased subcutaneous fat tissue in the nape of the neck may restrict the head extension and cause difficult intubation and difficult mask ventilation, and the increase in the chin-nape circumference may predict difficult intubation and difficult mask ventilation. We also predicted that the ratio of neck circumference to chin-nape circumference might predict difficult intubation and difficult mask ventilation.
Materials and Methods: After the approval of the ethics committee, obese patients who require tracheal intubation, undergo elective surgery, over the age of 18, with a body mass index (BMI) of more than 30 were evaluated. Patients with cervical spine anomaly, emergency procedures, known history of difficult intubation or upper respiratory tract disease, and planned awake intubation were excluded from the study. Mallampati score, mouth opening, upper lip bite test, distance between incisors, thyromental distance, sternomental distance and thyromental height were recorded. Using a tape measure, the neck circumference from the thyroid cartilage level and the chin-neck circumference from the mentum level were measured with the patient in a neutral position. The ratio of neck circumference to thyromental distance and the ratio of neck circumference to chin-nape circumference were calculated from these measurements. Mask ventilation was graded according to the method described by Han et al. After adequate muscle relaxation was achieved, tracheal intubation was performed with an appropriately sized Macintosh blade using direct laryngoscopy. Difficult intubation evaluation was performed using the Difficult Intubation Scale (IDS) based on seven variables.
Read more
Results: A statistically significant relationship was found between difficult intubation and the distance between incisors, neck circumference, neck circumference / thyromental distance, neck circumference / sternomental distance, and chin-nape circumference. In the multivariate regression analysis performed with these parameters, the distance between the incisors was <4.85 cm and the neck circumference> 41.5 cm was found to be independent risk factors for difficult intubation. A statistically significant relationship was found between difficult mask ventilation and age, male gender, OSAS, neck circumference, neck circumference / thyromental distance, neck circumference / sternomental distance, neck circumference / chin-nape circumference and chin-nape circumference. In the multivariate regression analysis performed with these parameters, it was determined that male gender and neck circumference thicker than 45.5 cm were independent risk factors for difficult mask ventilation.
Conclusion: The ratio of neck circumference to chin-nape circumference and chin-nape circumference are successful in predicting difficult mask ventilation in obese patients. While chin-nape circumference is successful in predicting difficult intubation in obese patients, neck circumference / chin-nape circumference is unsuccessful.
- Conditions
- Difficult Airway Intubation, Obesity Adult Onset
- Being tested
- intubation, mask ventilation
- Keywords
- neck circumference / chin-nape circumference, chin-nape circumference, difficult airway, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubationOther
intubation
mask ventilationOther
mask ventilation
| Study group | Role | What they receive |
|---|---|---|
| difficult intubation | patients with a difficult intubation score of 5 or more Receives: Other: intubation | |
| easy intubation | patients with difficult intubation score less than 5 Receives: Other: intubation | |
| difficult mask ventilation | group 3 and 4 by han mask ventilation grouping Receives: Other: mask ventilation | |
| easy mask ventilation | group 1 and 2 according to han mask ventilation grouping Receives: Other: mask ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters associated with difficult intubation in obese patients
mallampati score, cormack-lehane score, distance between incisors, neck circumference, ratio of neck circumference to thyromental distance, ratio of neck circumference to sternomental distance and chin-nape circumference
Measured: always
Secondary outcomes (1)
parameters associated with difficult mask ventilation in obese patients
age, gender, OSAS, neck circumference, chin-nape circumference, ratio of neck circumference to chin-nape circumference, ratio of neck circumference to thyromental distance, and ratio of neck circumference to sternomenal distance
Measured: always
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start12 Sep 2019
- Primary completion15 Feb 2020
- Study completion7 Jun 2020
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.
- 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
- 4 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Kecioren Education and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, adem selvi, Kecioren Education and Training Hospital
- Investigators
- adem selvi, uzman dr., Principal investigator, sorumlu araştırmacı
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712227
- Sponsor's protocol ID
- adem obez havayolu
- Acronym
- intubation
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: everything
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Ratio of Chin-neck Circumference and Neck Circumference to Chin-neck Circumference Predict Difficult Intubation in Obese Patients?
- ClinicalTrials.gov ID
- NCT04712227
- Acronym / sponsor ID
- intubation / adem obez havayolu
- Conditions
- Difficult Airway Intubation, Obesity Adult Onset
- Keywords
- neck circumference / chin-nape circumference, chin-nape circumference, difficult airway, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Kecioren Education and Training HospitalUniversity, hospital or other
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 7 Jun 2020 (actual)
- First posted
- 15 Jan 2021 (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.
Importance and Purpose of the Study: Proper management of the difficult airway is an important part of preventing anesthesia-related mortality and morbidity. Difficult airways, characterized by both difficult mask ventilation and difficult intubation, are common in obese patients. Many studies have shown an association between obesity or morbid obesity and difficult intubation. We thought that in obese patients, increased subcutaneous fat tissue in the nape of the neck may restrict the head extension and cause difficult intubation and difficult mask ventilation, and the increase in the chin-nape circumference may predict difficult intubation and difficult mask ventilation. We also predicted that the ratio of neck circumference to chin-nape circumference might predict difficult intubation and difficult mask ventilation.
Materials and Methods: After the approval of the ethics committee, obese patients who require tracheal intubation, undergo elective surgery, over the age of 18, with a body mass index (BMI) of more than 30 were evaluated. Patients with cervical spine anomaly, emergency procedures, known history of difficult intubation or upper respiratory tract disease, and planned awake intubation were excluded from the study. Mallampati score, mouth opening, upper lip bite test, distance between incisors, thyromental distance, sternomental distance and thyromental height were recorded. Using a tape measure, the neck circumference from the thyroid cartilage level and the chin-neck circumference from the mentum level were measured with the patient in a neutral position. The ratio of neck circumference to thyromental distance and the ratio of neck circumference to chin-nape circumference were calculated from these measurements. Mask ventilation was graded according to the method described by Han et al. After adequate muscle relaxation was achieved, tracheal intubation was performed with an appropriately sized Macintosh blade using direct laryngoscopy. Difficult intubation evaluation was performed using the Difficult Intubation Scale (IDS) based on seven variables.
Results: A statistically significant relationship was found between difficult intubation and the distance between incisors, neck circumference, neck circumference / thyromental distance, neck circumference / sternomental distance, and chin-nape circumference. In the multivariate regression analysis performed with these parameters, the distance between the incisors was <4.85 cm and the neck circumference> 41.5 cm was found to be independent risk factors for difficult intubation. A statistically significant relationship was found between difficult mask ventilation and age, male gender, OSAS, neck circumference, neck circumference / thyromental distance, neck circumference / sternomental distance, neck circumference / chin-nape circumference and chin-nape circumference. In the multivariate regression analysis performed with these parameters, it was determined that male gender and neck circumference thicker than 45.5 cm were independent risk factors for difficult mask ventilation.
Conclusion: The ratio of neck circumference to chin-nape circumference and chin-nape circumference are successful in predicting difficult mask ventilation in obese patients. While chin-nape circumference is successful in predicting difficult intubation in obese patients, neck circumference / chin-nape circumference is unsuccessful.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| difficult intubation | – | Other: intubationpatients with a difficult intubation score of 5 or more |
| easy intubation | – | Other: intubationpatients with difficult intubation score less than 5 |
| difficult mask ventilation | – | Other: mask ventilationgroup 3 and 4 by han mask ventilation grouping |
| easy mask ventilation | – | Other: mask ventilationgroup 1 and 2 according to han mask ventilation grouping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will be operated under general anesthesia with endotracheal intubation, aged 18 years and over, with body mass index (BMI≥30) and ASA 1-3
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 |
|---|---|---|
| intubationintubation | Other | difficult intubation, easy intubation |
| mask ventilationmask ventilation | Other | difficult mask ventilation, easy mask ventilation |
Primary outcome
Parameters associated with difficult intubation in obese patients
Time frame: always
mallampati score, cormack-lehane score, distance between incisors, neck circumference, ratio of neck circumference to thyromental distance, ratio of neck circumference to sternomental distance and chin-nape circumference
1 secondary outcome
parameters associated with difficult mask ventilation in obese patients
Time frame: always
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 15 Jan 2021.
- Individual participant dataSharing planned: Yes. everything
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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.
adem selvi, uzman dr. principal investigator
sorumlu araştırmacı
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 and Obesity Adult Onset, run by Kecioren Education and Training Hospital 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?
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 15 Jan 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 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?
Parameters associated with difficult intubation in obese patients (time frame: always). 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 15 Jan 2021.