Difficult LaryngoscopyNCT05881694
Accuracy of Upper Lip Bite Test and Measurement of Skin-to-epiglottis Distance in Predicting Difficult Laryngoscopy: a Prospective Observational Study
An observational study of Difficult Laryngoscopy and Upper Lip Bite Test, run by Cairo University.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Difficult Laryngoscopy, Upper Lip Bite Test
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2023to 5 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: adult patients (above >40 years) ,( BMI < 35) with ASA-PS I-III, scheduled for elective surgery under general anesthesia with tracheal intubation
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Difficult Laryngoscopy, Upper Lip Bite Test
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before start of anesthesia till intubation of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start30 May 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion5 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult LaryngoscopyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherin Refaat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881694
- Sponsor's protocol ID
- MS-122-2022
- Status last verified
- Jun 2023
- First submitted
- 21 May 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Combined Upper Lip Bite Test and Ultrasound Measurement of Skin-to-epiglottis Distance in Predicting Difficult Laryngoscopy: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05881694
- Acronym / sponsor ID
- MS-122-2022
- Conditions
- Difficult Laryngoscopy, Upper Lip Bite Test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 5 Oct 2023 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- adult patients (above >40 years) ,( BMI < 35) with ASA-PS I-III, scheduled for elective surgery under general anesthesia with tracheal intubation
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Laryngoscopy and Upper Lip Bite Test, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.