- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02589015
Correlation of Neck Circumference With Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Patients
Correlation of Neck Circumference With Difficult Mask Ventilation and Difficult Laryngoscopy in Morbidly Obese Turkish Patients: A Prospective Clinical Trial
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34098
- Istanbul University Cerrahpasa Medical Faculty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation of difficult laryngoscopy with neck circumference
Time Frame: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy.
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with neck circumference
Time Frame: Ventilation difficulty scale was assessed during mask ventilation
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation of difficult laryngoscopy with modified mallampati score
Time Frame: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy.
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with modified mallampati score
Time Frame: Ventilation difficulty scale was assessed after during mask ventilation
|
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
|
|
Correlation of difficult laryngoscopy with neck movement
Time Frame: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy.
|
Cormack Lehane score was assessed during laryngoscopy
|
|
with neck movement
Time Frame: Ventilation difficulty scale was assessed during mask ventilation
|
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
|
|
Correlation of difficult laryngoscopy with dentition
Time Frame: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy.
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with dentition
Time Frame: Ventilation difficulty scale was assessed during mask ventilation
|
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
|
|
Correlation of difficult laryngoscopy with upper lip bite test
Time Frame: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with upper lip bite test
Time Frame: Ventilation difficulty scale was assessed during mask ventilation
|
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
|
|
Correlation of difficult laryngoscopy with mouth opening
Time Frame: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with mouth opening
Time Frame: Ventilation difficulty scale was assessed during mask ventilation
|
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
|
|
Correlation of difficult laryngoscopy with sternomental distance
Time Frame: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with sternomental distance
Time Frame: Ventilation difficulty scale was assessed during mask ventilation
|
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
|
|
Correlation of difficult laryngoscopy with breast circumference
Time Frame: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with breast circumference
Time Frame: Ventilation difficulty scale was assessed during mask ventilation
|
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
|
|
Correlation of difficult laryngoscopy with thorax circumference
Time Frame: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with thorax circumference
Time Frame: Ventilation difficulty scale was assessed during mask ventilation
|
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
|
|
Correlation of difficult laryngoscopy with waist circumference
Time Frame: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with waist circumference
Time Frame: Ventilation difficulty scale was assessed during mask ventilation
|
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
|
|
Correlation of difficult laryngoscopy with hip circumference
Time Frame: Cormack Lehane score was assessed during laryngoscopy
|
Cormack Lehane scores III and IV were defined as difficult laryngoscopy
|
Cormack Lehane score was assessed during laryngoscopy
|
|
Correlation of difficult mask ventilation with hip circumference
Time Frame: Ventilation difficulty scale was assessed during mask ventilation
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Güniz Köksal, Professor, Istanbul University Cerrahpasa Medical Faculty
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-887/2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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