Correlation of Neck Circumference With Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Patients

Morbid Obesity Clinical Trial

Official title:

Correlation of Neck Circumference With Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Turkish Patients: A Prospective Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589015
• Other study ID #: 02-887/2
• Status: Completed
• Phase: N/A
• First received: August 20, 2015
• Last updated: February 10, 2016
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of difficult laryngoscopy with neck circumference	Cormack Lehane scores III and IV were defined as difficult laryngoscopy.	Cormack Lehane score was assessed during laryngoscopy	No
Primary	Correlation of difficult mask ventilation with neck circumference	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.	Ventilation difficulty scale was assessed during mask ventilation	No
Secondary	Correlation of difficult laryngoscopy with modified mallampati score	Cormack Lehane scores III and IV were defined as difficult laryngoscopy.	Cormack Lehane score was assessed during laryngoscopy	No
Secondary	Correlation of difficult mask ventilation with modified mallampati score	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.	Ventilation difficulty scale was assessed after during mask ventilation	No
Secondary	Correlation of difficult laryngoscopy with neck movement	Cormack Lehane scores III and IV were defined as difficult laryngoscopy.	Cormack Lehane score was assessed during laryngoscopy	No
Secondary	with neck movement	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.	Ventilation difficulty scale was assessed during mask ventilation	No
Secondary	Correlation of difficult laryngoscopy with dentition	Cormack Lehane scores III and IV were defined as difficult laryngoscopy.	Cormack Lehane score was assessed during laryngoscopy	No
Secondary	Correlation of difficult mask ventilation with dentition	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.	Ventilation difficulty scale was assessed during mask ventilation	No
Secondary	Correlation of difficult laryngoscopy with upper lip bite test	Cormack Lehane scores III and IV were defined as difficult laryngoscopy	Cormack Lehane score was assessed during laryngoscopy	No
Secondary	Correlation of difficult mask ventilation with upper lip bite test	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.	Ventilation difficulty scale was assessed during mask ventilation	No
Secondary	Correlation of difficult laryngoscopy with mouth opening	Cormack Lehane scores III and IV were defined as difficult laryngoscopy	Cormack Lehane score was assessed during laryngoscopy	No
Secondary	Correlation of difficult mask ventilation with mouth opening	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.	Ventilation difficulty scale was assessed during mask ventilation	No
Secondary	Correlation of difficult laryngoscopy with sternomental distance	Cormack Lehane scores III and IV were defined as difficult laryngoscopy	Cormack Lehane score was assessed during laryngoscopy	No
Secondary	Correlation of difficult mask ventilation with sternomental distance	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.	Ventilation difficulty scale was assessed during mask ventilation	No
Secondary	Correlation of difficult laryngoscopy with breast circumference	Cormack Lehane scores III and IV were defined as difficult laryngoscopy	Cormack Lehane score was assessed during laryngoscopy	No
Secondary	Correlation of difficult mask ventilation with breast circumference	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.	Ventilation difficulty scale was assessed during mask ventilation	No
Secondary	Correlation of difficult laryngoscopy with thorax circumference	Cormack Lehane scores III and IV were defined as difficult laryngoscopy	Cormack Lehane score was assessed during laryngoscopy	No
Secondary	Correlation of difficult mask ventilation with thorax circumference	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.	Ventilation difficulty scale was assessed during mask ventilation	No
Secondary	Correlation of difficult laryngoscopy with waist circumference	Cormack Lehane scores III and IV were defined as difficult laryngoscopy	Cormack Lehane score was assessed during laryngoscopy	No
Secondary	Correlation of difficult mask ventilation with waist circumference	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.	Ventilation difficulty scale was assessed during mask ventilation	No
Secondary	Correlation of difficult laryngoscopy with hip circumference	Cormack Lehane scores III and IV were defined as difficult laryngoscopy	Cormack Lehane score was assessed during laryngoscopy	No
Secondary	Correlation of difficult mask ventilation with hip circumference	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.	Ventilation difficulty scale was assessed during mask ventilation	No