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Sternomental Displacement Test for Predicting Difficult Airway in Obese Patients

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ClinicalTrials.gov Identifier: NCT04524546
Recruitment Status : Completed
First Posted : August 24, 2020
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Abeer Ahmed, MD, Cairo University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Difficult Airway Intubation Diagnostic Test: Sterno-mental displacement test

Study Design
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Study Type : Observational
Actual Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sternomental Displacement and Neck Circumference as Predictors of Difficult Airway in Obese Patients During General Anesthesia: a Prospective Observational Cohort Study
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : February 20, 2021
Actual Study Completion Date : April 30, 2021
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Sterno-mental displacement test
    While the patient is in sitting position, (SMD neutral) will be is measured using tape as the distance between upper borders of the manubrium sterni to the mentum with the head in a neutral position. The (SMD extension) will be then measured in the same way with the head extended on the neck. The difference between SMD extension and SMD neutral will be then calculated as sternomental displacement (SMDD).

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524546


Locations
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Egypt
Anesthesia department - Faculty of medicine- Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Abeer Ahmed, MD, Assistant Professor of Anesthesia, SICU & pain management. Kasralainy Faculty of medicine, Cairo University
ClinicalTrials.gov Identifier: NCT04524546    
Other Study ID Numbers: Ms-141-2020
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No