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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04524546
Other study ID # Ms-141-2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date April 30, 2021

Study information

Verified date May 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date April 30, 2021
Est. primary completion date February 20, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Egypt Anesthesia department - Faculty of medicine- Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. before induction of general anesthesia
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