AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT04712227
Study groupRoleWhat they receive
difficult intubationpatients with a difficult intubation score of 5 or more
Receives: Other: intubation
easy intubationpatients with difficult intubation score less than 5
Receives: Other: intubation
difficult mask ventilationgroup 3 and 4 by han mask ventilation grouping
Receives: Other: mask ventilation
easy mask ventilationgroup 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.

  1. 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)
  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.

  1. First posted15 Jan 2021
  2. Study start12 Sep 2019
  3. Primary completion15 Feb 2020
  4. Study completion7 Jun 2020

Resources

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
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in