- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04524546
Sternomental Displacement Test for Predicting Difficult Airway in Obese Patients
May 14, 2021 updated by: Abeer Ahmed, MD, Cairo University
Sternomental Displacement and Neck Circumference as Predictors of Difficult Airway in Obese Patients During General Anesthesia: a Prospective Observational Cohort Study
Difficulties airway significantly contribute to the morbidity and mortality associated with anesthesia.
Identifying situations and patients at risk for airway management problems is the key to optimal care and has been the focus of numerous publications.
Although controversial, Body Mass Index (BMI) is considered as associated with difficult intubation in both and operating theaters.
A modified measurement of SMD is obtained with the head in neutral position (SMD neutral), then the difference between SMD extension and SMD neutral was calculated and it was referred to as sternomental displacement (SMDD).
SMDD was proved to be a good objective predictor for difficult laryngoscopy in adult patients, and its predictive ability was increased when combined with other tests as neck circumference (NC).
To the best of our knowledge, the validity of the SMDD test was not previously assessed in obese patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
135
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt
- Anesthesia department - Faculty of medicine- Cairo University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients of either sex, aged between 18-60 years old, ASA physical status II & III with BMI > 30 Kg/m2
Description
Inclusion Criteria:
- Patients of either sex, aged between 18-60 years old, ASA physical status II & III with BMI > 30 Kg/m2 undergoing elective surgical procedures under general anesthesia using endotracheal intubation by conventional laryngoscopy.
Exclusion Criteria:
- neuromuscular disorders, craniofacial abnormalities, abnormal dentition, lesions or scares in head and neck limiting the neck mobility, uncooperative, who needed awake intubation and patients who underwent emergency operations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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A a cut-off value, sensitivity (Sn), specificity (Sp), positive predictive values (PPV), negative predictive values (NPV) of sternomental displacement in predicting difficult laryngoscopy in obese patient undergoing GA.
Time Frame: before induction of general anesthesia
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before induction of general anesthesia
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2020
Primary Completion (ACTUAL)
February 20, 2021
Study Completion (ACTUAL)
April 30, 2021
Study Registration Dates
First Submitted
August 20, 2020
First Submitted That Met QC Criteria
August 21, 2020
First Posted (ACTUAL)
August 24, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 18, 2021
Last Update Submitted That Met QC Criteria
May 14, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Ms-141-2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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