NCT05881694

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

May 21, 2023

Last Update Submit

June 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant professor of anesthiology ,faculty of medcine ,Cairo univeristy

Study Record Dates

First Submitted

May 21, 2023

First Posted

May 31, 2023

Study Start

May 30, 2023

Primary Completion

October 1, 2023

Study Completion

October 5, 2023

Last Updated

June 6, 2023

Record last verified: 2023-06