Can the Ratio of Chin-neck Circumference and Neck Circumference to Chin-neck Circumference Predict Difficult Intubation in Obese Patients?

NCT04712227 | Completed

• 1 other identifier: adem obez havayolu
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Difficult Airway Intubation; Obesity Adult Onset

Keywords

neck circumference / chin-nape circumference; chin-nape circumference; difficult airway; obesity

Outcome Measures

Primary Outcomes (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

  always

Secondary Outcomes (1)

• parameters associated with difficult mask ventilation in obese patients

  always

Study Arms (4)

difficult intubation

patients with a difficult intubation score of 5 or more

Other: intubation

easy intubation

patients with difficult intubation score less than 5

Other: intubation

difficult mask ventilation

group 3 and 4 by han mask ventilation grouping

Other: mask ventilation

easy mask ventilation

group 1 and 2 according to han mask ventilation grouping

Other: mask ventilation

Interventions

intubation OTHER

intubation

difficult intubation; easy intubation

mask ventilation OTHER

mask ventilation

difficult mask ventilation; easy mask ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

Sponsors & Collaborators

• Kecioren Education and Training Hospital: lead

Study Sites (1)

Keçiören training and research hospital

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Interventions

Intubation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• adem selvi, uzman dr.

  sorumlu araştırmacı

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: uzman doktor

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 15, 2021
• Study Start: September 12, 2019
• Primary Completion: February 15, 2020
• Study Completion: June 7, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months
• Access Criteria: difficult airway obesity

Locations

TU (1)