- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02366182
Does Neck Circumference Help to Predict Difficult Airway in Obstetric Patients?
Failed intubation and ventilation in obstetrics remains one of the most common causes of death directly related to anesthesia. The reported incidence of failed intubation in obstetrics is 1:300, which is significantly higher than that in the non-obstetric population. A clinical screening test with high sensitivity and specificity for prediction of difficult airway may help reduce morbidity and mortality from general anesthesia. Few studies have identified increased neck circumference as the best single predictor of problematic intubation. However the cutoff point of this test for identifying patients at high risk of difficult intubation is not clear.
The aim of this study is to determine the optimal cutoff point, which validates prediction of difficult ventilation and/or intubation for obstetric patients. Preoperative airway assessment will be done including neck circumference. Intraoperative difficult ventilation and/or intubation will be recorded. Optimal cutoff point of neck circumference will be calculated by Receiver Operating characteristics (ROC) curve.
Study Overview
Status
Conditions
Detailed Description
In this prospective study, patients will be assessed by the anaesthetist preoperatively and asked about their medical history including detailed history of obstructive sleep apnea (OSA) and snoring. Physical examination including weight,height &BMI .
Airway assessment will include:
- Maximum mouth opening measured as interincisor gap (mm).
- Sternomental distance measured as the straight distance between the upper border of manubrium sterni and the bony point of the mentum with the head in full extension and the mouth is closed (cm).
- Hyomental distance measured from just above the hyoid bone to the tip to the anterior-most part of the mentum in both neutral position and with maximum head extension (cm). Hence, hyomental distance ratio (HMDR) will be calculated.
- Thyromental distance measured as the distance from the thyroid notch to the inner margin of the mental prominence when the head is fully extended (cm).
- Extended Mallampati Score (EMS) in sitting position with full extension of craniocervical junction with phonation (class I: Entire Uvula is clearly visible; class II: Upper half of the uvula is visible; class III: soft and hard palate clearly visible; and class IV: Only hard palate is visible).
- Neck Circumference at the level of the thyroid cartilage (cm).
- Condition of the teeth (Protrusion, loose, missing).
- Mandibular protrusion test to detect temporomandibular joint mobility measured as ability to move the lower teeth in front of the upper teeth.
Intubation will be considered difficult if the Intubation Difficulty Scale ( IDS) is equal or more than 5 .
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Abu Dhabi, United Arab Emirates, 3788
- Corniche Hospital
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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:
- Patients scheduled for cesarean section under general anesthesia
Exclusion Criteria:
- Patients with upper airway pathology
- Patients with cervical spine abnormality
- Emergency cesarean section
- Known cases of difficult intubation
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difficult intubation
Time Frame: 5 minutes
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Difficult intubation defined as Intubation difficulty scale (IDS) >5
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5 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Waleed Riad, MD, Corniche Hospital
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
Other Study ID Numbers
- Ch09101401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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