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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05881694
Other study ID # MS-122-2022
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 30, 2023
Est. completion date October 5, 2023

Study information

Verified date June 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Airway management is one of the most important skills in everyday practice of anesthesia. Improper airway management might lead to high risk of mortality. clinical parameters alone cannot predict all potentially difficult airways. Ultrasonography (US) might play a role as a potential screening tool for difficult airway and given the limited empirical study in this field; this research will focus on using ultrasound to predict difficult airway and difficult mask ventilation for patients undergoing elective operation under general anesthesia. Methodology This study is Prospective observational . The study will be conducted in Cairo University Hospital Participants are adult patients (above >40 years), (BMI < 35) with American Society of Anesthesiologists physical status (ASA-PS) I-III, scheduled for elective surgery under general anesthesia with tracheal intubation . Exclusion criteria included patients with history of difficult intubation or apparent airway abnormalities (facial scars, neck scars, unstable cervical spine and history of cervical spine fixation) that would require alternative technique other than endotracheal intubation with direct laryngoscopy. Also, edentulous patients, patients undergoing emergency procedure and pregnant women are excluded from the study. Hypothesis The investigators hypothesize that combined class 3 ULBT and DSE >2 cm can accurately predict difficult laryngoscopy in adult patients undergoing elective procedure under general anesthesia with endotracheal intubation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 210
Est. completion date October 5, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Participants will be adult patients (above >40 years) ( BMI < 35) with ASA-PS I-III, scheduled for elective surgery under general anesthesia with tracheal intubation. Exclusion Criteria: - Patients with history of difficult intubation or apparent airway abnormalities (facial scars, neck scars, unstable cervical spine and history of cervical spine fixation) that would require alternative technique other than endotracheal intubation. Edentulous patients patients undergoing emergency procedure pregnant women were excluded from the study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary The accuracy of combined class 3 ULBT and DSE >2 cm in predicting difficult laryngoscopy The ULBT was performed by asking the patient to bite their upper lip with the lower incisors as high as they could While the patient was in supine position with the head in neutral position, the transducer was placed in the transverse plane at the level of the thyrohyoid membrane. The epiglottis was visible through the thyrohyoid membrane as a hypoechoic curvilinear structure with its posterior border demarcated by a bright hyperechoic linear air-mucosal interface. For each patient, the distance from the skin to the epiglottis was measured three times at the central axis of the epiglottis and the average of the measurement was calculated. before start of anesthesia till intubation of the patient
See also
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Completed NCT04711018 - Comparison of Various Measures for Anticipating Difficult Laryngoscopy
Completed NCT01719848 - Evaluation of Clinical Airway Assessments With a Gray Zone Approach N/A