Clinical trial NCT02589015: Correlation of Neck Circumference With Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Patients
Official title: Correlation of Neck Circumference With Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Turkish Patients: A Prospective Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: morbid obesity
neck circumference
difficult mask ventilation
difficult laryngoscopy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with body mass index (BMI) \> = 40, applied for elective surgery.

Brief summary: The aim of this study is to determine the correlation of neck circumference with difficult mask ventilation and laryngoscopy in morbidly obese patients.

Detailed description: Patients' Mallampati score, upper lip bite test, neck mobility, teeth abnormalities were evaluated preoperatively. Mouth opening, sternomental and thyromental distances, neck circumference, thoracic circumference, breast circumference , belly circumference and hip circumference were measured preoperatively.

After anesthesia induciton with propofol and rocuronium, patients' mask ventilation difficulty was evaluated as defined below: V1- Ventilated by single anesthesist easily; V2- Ventilated by single anesthesist with oral airway; V3- Ventilated by two anesthesists; V4- Unable to mask ventilate. V3 and V4 was defined as difficult mask ventilation.

Laringoscopy was performed with MacIntosh laryngoscop and Cormack Lehane (CL) score was evaluated. CL score III and IV were defined as difficult laryngoscopy.

Eligibility criteria: Inclusion Criteria:

* BMI \>= 40
* American Society of Anesthesiologists (ASA) Physical Status I-III
* Patients applied for elective surgery

Exclusion Criteria:

* BMI \< 40
* maxillofacial tumor or fracture
* mass at the neck
* mass in the thorax or mediastina
* scar at the neck area
* previous radiotherapy history to neck area
* history of cervical vertebra operations
* cervical vertebra structure abnormality

Primary outcomes:
measure: Correlation of difficult laryngoscopy with neck circumference
timeFrame: Cormack Lehane score was assessed during laryngoscopy
measure: Correlation of difficult mask ventilation with neck circumference
timeFrame: Ventilation difficulty scale was assessed during mask ventilation
Secondary outcomes:
measure: Correlation of difficult laryngoscopy with modified mallampati score
timeFrame: Cormack Lehane score was assessed during laryngoscopy
measure: Correlation of difficult mask ventilation with modified mallampati score
timeFrame: Ventilation difficulty scale was assessed after during mask ventilation
measure: Correlation of difficult laryngoscopy with neck movement
timeFrame: Cormack Lehane score was assessed during laryngoscopy
measure: with neck movement
timeFrame: Ventilation difficulty scale was assessed during mask ventilation
measure: Correlation of difficult laryngoscopy with dentition
timeFrame: Cormack Lehane score was assessed during laryngoscopy
measure: Correlation of difficult mask ventilation with dentition
timeFrame: Ventilation difficulty scale was assessed during mask ventilation
measure: Correlation of difficult laryngoscopy with upper lip bite test
timeFrame: Cormack Lehane score was assessed during laryngoscopy
measure: Correlation of difficult mask ventilation with upper lip bite test
timeFrame: Ventilation difficulty scale was assessed during mask ventilation
measure: Correlation of difficult laryngoscopy with mouth opening
timeFrame: Cormack Lehane score was assessed during laryngoscopy
measure: Correlation of difficult mask ventilation with mouth opening
timeFrame: Ventilation difficulty scale was assessed during mask ventilation
measure: Correlation of difficult laryngoscopy with sternomental distance
timeFrame: Cormack Lehane score was assessed during laryngoscopy
measure: Correlation of difficult mask ventilation with sternomental distance
timeFrame: Ventilation difficulty scale was assessed during mask ventilation
measure: Correlation of difficult laryngoscopy with breast circumference
timeFrame: Cormack Lehane score was assessed during laryngoscopy
measure: Correlation of difficult mask ventilation with breast circumference
timeFrame: Ventilation difficulty scale was assessed during mask ventilation
measure: Correlation of difficult laryngoscopy with thorax circumference
timeFrame: Cormack Lehane score was assessed during laryngoscopy
measure: Correlation of difficult mask ventilation with thorax circumference
timeFrame: Ventilation difficulty scale was assessed during mask ventilation
measure: Correlation of difficult laryngoscopy with waist circumference
timeFrame: Cormack Lehane score was assessed during laryngoscopy
measure: Correlation of difficult mask ventilation with waist circumference
timeFrame: Ventilation difficulty scale was assessed during mask ventilation
measure: Correlation of difficult laryngoscopy with hip circumference
timeFrame: Cormack Lehane score was assessed during laryngoscopy
measure: Correlation of difficult mask ventilation with hip circumference
timeFrame: Ventilation difficulty scale was assessed during mask ventilation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
Study officials:
affiliation: Istanbul University Cerrahpasa Medical Faculty
name: Güniz Köksal, Professor
role: STUDY_DIRECTOR
References:
citation: Ozdilek A, Beyoglu CA, Erbabacan SE, Ekici B, Altindas F, Vehid S, Koksal GM. Correlation of Neck Circumference with Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Patients: an Observational Study. Obes Surg. 2018 Sep;28(9):2860-2867. doi: 10.1007/s11695-018-3263-3.