Accuracy of Upper Lip Bite Test and Measurement of Skin-to-epiglottis Distance in Predicting Difficult Laryngoscopy: a Prospective Observational Study

June 3, 2023 updated by: Sherin Refaat, Cairo University

Accuracy of Combined Upper Lip Bite Test and Ultrasound Measurement of Skin-to-epiglottis Distance in Predicting Difficult Laryngoscopy: a Prospective Observational Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

210

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult patients (above >40 years) ,( BMI < 35) with ASA-PS I-III, scheduled for elective surgery under general anesthesia with tracheal intubation

Description

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 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
Measure Description
Time Frame
The accuracy of combined class 3 ULBT and DSE >2 cm in predicting difficult laryngoscopy
Time Frame: before start of anesthesia till intubation of the patient
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

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 (Estimated)

May 30, 2023

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

October 5, 2023

Study Registration Dates

First Submitted

May 21, 2023

First Submitted That Met QC Criteria

May 21, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 3, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-122-2022

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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