UltrasonographicNCT07315256
Combined Ultrasonographic Skin-to-Epiglottis Distance With Modified Mallampati Versus Modified Mallampati Score Alone in Predicting Difficult Laryngoscopy During Tracheal Intubation Under General Anesthesia
A study testing Ultrasound-Guided Skin-to-Epiglottis Distance Measurement and Clinical Airway Assessment With Modified Mallampati Score in people with Ultrasonographic and Mallampati Score, run by Assiut University.
Trial summary
This study will evaluate how well an ultrasound measurement of the distance from the skin to the epiglottis, when combined with the modified Mallampati score, can predict difficult laryngoscopy in adult patients undergoing elective surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ultrasonographic, Mallampati Score, Mallampati Score, Difficult Intubation, Videolaryngoscope
- What is being tested?
- Ultrasound-Guided Skin-to-Epiglottis Distance Measurement and Clinical Airway Assessment With Modified Mallampati Score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- ASA physical status I-II.
- Scheduled for elective surgery under general anesthesia requiring tracheal intubation with direct laryngoscopy.
- Able to provide written informed consent.
Who cannot join
- Emergency surgery.
- Known or suspected difficult airway requiring planned alternative intubation technique (e.g., awake fiberoptic).
- History of significant upper airway pathology, neck mass, prior neck surgery, or radiation affecting airway anatomy.
- Limited mouth opening, cervical spine instability, or contraindication to standard sniffing position.
- Pregnancy.
- Refusal or inability to provide informed consent.
About this study
Official title: Combined Ultrasonographic Skin-to-Epiglottis Distance With Modified Mallampati Versus Modified Mallampati Score Alone in Predicting Difficult Laryngoscopy During Tracheal Intubation Under General Anesthesia: A Prospective, Randomized Double Blinded Controlled Study
This study will evaluate how well an ultrasound measurement of the distance from the skin to the epiglottis, when combined with the modified Mallampati score, can predict difficult laryngoscopy in adult patients undergoing elective surgery under general anesthesia. Adult patients scheduled for surgery requiring tracheal intubation will be randomly assigned to two assessment strategies before anesthesia: one group will have the usual bedside airway assessment with modified Mallampati alone, and the other group will have modified Mallampati plus a quick, painless ultrasound scan of the front of the neck to measure the skin-to-epiglottis distance. During intubation, the anesthesiologist, who is blinded to the preoperative assessments, will grade the laryngoscopic view using the Cormack-Lehane classification, and the investigators will compare how accurately each assessment approach predicts difficult laryngoscopy (grade 3-4). The study does not change how anesthesia or airway management is performed; ultrasound and clinical assessments are added solely for measurement and data collection, with minimal risk to participants and potential future benefits in improving airway risk stratification and patient safety.
Read the detailed description
This is a prospective, randomized, double-blinded controlled study designed to evaluate whether combining preoperative ultrasonographic skin-to-epiglottis distance (SED) with the modified Mallampati score improves prediction of difficult laryngoscopy compared with the modified Mallampati score alone in adult elective surgical patients undergoing tracheal intubation under general anesthesia. Eligible patients will be randomly assigned to one of two groups: Group A will undergo standard preoperative airway assessment including modified Mallampati score only, while Group B will receive both modified Mallampati assessment and ultrasound measurement of SED using a standardized anterior neck scanning protocol in the preoperative area.
All patients will subsequently undergo direct laryngoscopy for tracheal intubation in the operating room, performed by an experienced anesthesiologist who is blinded to the preoperative airway assessment results; the Cormack-Lehane laryngoscopic view during the first intubation attempt will be recorded as the reference standard for defining difficult laryngoscopy (grade 3-4). Additional data collected will include age, sex, body mass index, relevant comorbidities, and type of surgery to allow adjustment for potential confounders. The primary endpoint is the diagnostic accuracy (area under the receiver operating characteristic curve) of SED plus modified Mallampati versus modified Mallampati alone for predicting difficult laryngoscopy. Secondary endpoints include the correlation of SED with Cormack-Lehane grade, sensitivity, specificity, and predictive values of each assessment strategy, and exploratory subgroup analyses in higher-risk patients such as those with obesity.
- Conditions
- Ultrasonographic, Mallampati Score, Mallampati Score, Difficult Intubation, Videolaryngoscope, Tracheal Intubation
- Being tested
- Ultrasound-Guided Skin-to-Epiglottis Distance Measurement, Clinical Airway Assessment With Modified Mallampati Score
- Keywords
- Difficult Laryngoscopy, Tracheal Intubation, Modified Mallampati
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Skin-to-Epiglottis Distance MeasurementDiagnostic test
Point-of-care airway ultrasound of the anterior neck using a high-frequency linear probe (10-13 MHz) placed transversely at the thyrohyoid membrane to measure the vertical skin-to-epiglottis distance in millimeters. The scan is performed preoperatively in supine neutral position, is non-invasive and painless, and does not alter anesthetic or airway management, which follow standard clinical practice. This measurement is combined with the modified Mallampati score in the experimental arm to predict difficult laryngoscopy (Cormack-Lehane grade 3-4).
Clinical Airway Assessment With Modified Mallampati ScoreDiagnostic test
Standard preoperative bedside airway assessment using the modified Mallampati score without airway ultrasound; performed in the sitting position with mouth opening and maximal tongue protrusion, used routinely to anticipate difficulty of laryngoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Modified Mallampati Only | Active comparator | Adult elective surgical patients will undergo standard preoperative airway assessment using the modified Mallampati score only. No airway ultrasound will be performed. An experienced anesthesiologist, blinded to all preoperative assessments, will perform direct laryngoscopy for tracheal intubation and record the Cormack-Lehane grade on first attempt. Receives: Diagnostic Test: Clinical Airway Assessment With Modified Mallampati Score |
| Mallampati Plus Ultrasound Skin-to-Epiglottis Distance | Experimental | Adult elective surgical patients will undergo standard preoperative airway assessment with the modified Mallampati score plus point-of-care airway ultrasound to measure the midline skin-to-epiglottis distance using a high-frequency linear probe at the thyrohyoid membrane. The measurement is non-invasive and does not change clinical management. An experienced anesthesiologist, blinded to both Mallampati and ultrasound results, will perform direct laryngoscopy for tracheal intubation and record the Cormack-Lehane grade on first attempt. Receives: Diagnostic Test: Ultrasound-Guided Skin-to-Epiglottis Distance Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of Ultrasonographic Skin-to-Epiglottis Distance plus Mallampati vs Mallampati alone for difficult laryngoscopy
Area under the receiver operating characteristic (ROC) curve (AUC) of the combined ultrasound skin-to-epiglottis distance plus modified Mallampati score compared with the AUC of the modified Mallampati score alone for predicting difficult laryngoscopy, defined as Cormack-Lehane grade 3-4 on first direct laryngoscopy attempt.
Measured: From induction of anesthesia to completion of first direct laryngoscopy (intraoperative, approximately 10 minutes).
Secondary outcomes (1)
Correlation between skin-to-epiglottis distance and Cormack-Lehane grade
Pearson or Spearman correlation coefficient between the ultrasound-measured midline skin-to-epiglottis distance and the Cormack-Lehane laryngoscopic grade recorded on the first intubation attempt in all patients who undergo airway ultrasound.
Measured: From preoperative ultrasound assessment to completion of first direct laryngoscopy (same operative session, approximately 30 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographicStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Abdullah Badawy Abdullah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315256
- Sponsor's protocol ID
- Ultrasound in Intubation
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Ultrasonographic Skin-to-Epiglottis Distance With Modified Mallampati Versus Modified Mallampati Score Alone in Predicting Difficult Laryngoscopy During Tracheal Intubation Under General Anesthesia: A Prospective, Randomized Double Blinded Controlled Study
- ClinicalTrials.gov ID
- NCT07315256
- Acronym / sponsor ID
- Ultrasound in Intubation
- Conditions
- Ultrasonographic, Mallampati Score, Mallampati Score, Difficult Intubation, Videolaryngoscope, Tracheal Intubation
- Keywords
- Difficult Laryngoscopy, Tracheal Intubation, Modified Mallampati
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Jan 2026 (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.
This study will evaluate how well an ultrasound measurement of the distance from the skin to the epiglottis, when combined with the modified Mallampati score, can predict difficult laryngoscopy in adult patients undergoing elective surgery under general anesthesia. Adult patients scheduled for surgery requiring tracheal intubation will be randomly assigned to two assessment strategies before anesthesia: one group will have the usual bedside airway assessment with modified Mallampati alone, and the other group will have modified Mallampati plus a quick, painless ultrasound scan of the front of the neck to measure the skin-to-epiglottis distance. During intubation, the anesthesiologist, who is blinded to the preoperative assessments, will grade the laryngoscopic view using the Cormack-Lehane classification, and the investigators will compare how accurately each assessment approach predicts difficult laryngoscopy (grade 3-4). The study does not change how anesthesia or airway management is performed; ultrasound and clinical assessments are added solely for measurement and data collection, with minimal risk to participants and potential future benefits in improving airway risk stratification and patient safety.
Detailed description
This is a prospective, randomized, double-blinded controlled study designed to evaluate whether combining preoperative ultrasonographic skin-to-epiglottis distance (SED) with the modified Mallampati score improves prediction of difficult laryngoscopy compared with the modified Mallampati score alone in adult elective surgical patients undergoing tracheal intubation under general anesthesia. Eligible patients will be randomly assigned to one of two groups: Group A will undergo standard preoperative airway assessment including modified Mallampati score only, while Group B will receive both modified Mallampati assessment and ultrasound measurement of SED using a standardized anterior neck scanning protocol in the preoperative area.
All patients will subsequently undergo direct laryngoscopy for tracheal intubation in the operating room, performed by an experienced anesthesiologist who is blinded to the preoperative airway assessment results; the Cormack-Lehane laryngoscopic view during the first intubation attempt will be recorded as the reference standard for defining difficult laryngoscopy (grade 3-4). Additional data collected will include age, sex, body mass index, relevant comorbidities, and type of surgery to allow adjustment for potential confounders. The primary endpoint is the diagnostic accuracy (area under the receiver operating characteristic curve) of SED plus modified Mallampati versus modified Mallampati alone for predicting difficult laryngoscopy. Secondary endpoints include the correlation of SED with Cormack-Lehane grade, sensitivity, specificity, and predictive values of each assessment strategy, and exploratory subgroup analyses in higher-risk patients such as those with obesity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Mallampati Only | Active comparator | Diagnostic Test: Clinical Airway Assessment With Modified Mallampati ScoreAdult elective surgical patients will undergo standard preoperative airway assessment using the modified Mallampati score only. No airway ultrasound will be performed. An experienced anesthesiologist, blinded to all preoperative assessments, will perform direct laryngoscopy for tracheal intubation and record the Cormack-Lehane grade on first attempt. |
| Mallampati Plus Ultrasound Skin-to-Epiglottis Distance | Experimental | Diagnostic Test: Ultrasound-Guided Skin-to-Epiglottis Distance MeasurementAdult elective surgical patients will undergo standard preoperative airway assessment with the modified Mallampati score plus point-of-care airway ultrasound to measure the midline skin-to-epiglottis distance using a high-frequency linear probe at the thyrohyoid membrane. The measurement is non-invasive and does not change clinical management. An experienced anesthesiologist, blinded to both Mallampati and ultrasound results, will perform direct laryngoscopy for tracheal intubation and record the Cormack-Lehane grade on first attempt. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-65 years.
- ASA physical status I-II.
- Scheduled for elective surgery under general anesthesia requiring tracheal intubation with direct laryngoscopy.
- Able to provide written informed consent.
Key exclusion criteria (6 listed)
- Emergency surgery.
- Known or suspected difficult airway requiring planned alternative intubation technique (e.g., awake fiberoptic).
- History of significant upper airway pathology, neck mass, prior neck surgery, or radiation affecting airway anatomy.
- Limited mouth opening, cervical spine instability, or contraindication to standard sniffing position.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Skin-to-Epiglottis Distance MeasurementPoint-of-care airway ultrasound of the anterior neck using a high-frequency linear probe (10-13 MHz) placed transversely at the thyrohyoid membrane to measure the vertical skin-to-epiglottis distance in millimeters. The scan is performed preoperatively in supine neutral position, is non-invasive and painless, and does not alter anesthetic or airway management, which follow standard clinical practice. This measurement is combined with the modified Mallampati score in the experimental arm to predict difficult laryngoscopy (Cormack-Lehane grade 3-4). | Diagnostic test | Mallampati Plus Ultrasound Skin-to-Epiglottis Distance |
| Clinical Airway Assessment With Modified Mallampati ScoreStandard preoperative bedside airway assessment using the modified Mallampati score without airway ultrasound; performed in the sitting position with mouth opening and maximal tongue protrusion, used routinely to anticipate difficulty of laryngoscopy. | Diagnostic test | Modified Mallampati Only |
Primary outcome
Diagnostic accuracy of Ultrasonographic Skin-to-Epiglottis Distance plus Mallampati vs Mallampati alone for difficult laryngoscopy
Time frame: From induction of anesthesia to completion of first direct laryngoscopy (intraoperative, approximately 10 minutes).
Area under the receiver operating characteristic (ROC) curve (AUC) of the combined ultrasound skin-to-epiglottis distance plus modified Mallampati score compared with the AUC of the modified Mallampati score alone for predicting difficult laryngoscopy, defined as Cormack-Lehane grade 3-4 on first direct laryngoscopy attempt.
1 secondary outcome
Correlation between skin-to-epiglottis distance and Cormack-Lehane grade
Time frame: From preoperative ultrasound assessment to completion of first direct laryngoscopy (same operative session, approximately 30 minutes).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Skin-to-Epiglottis Distance Measurement and Clinical Airway Assessment With Modified Mallampati Score in people with Ultrasonographic and Mallampati Score, run by Assiut 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic accuracy of Ultrasonographic Skin-to-Epiglottis Distance plus Mallampati vs Mallampati alone for difficult laryngoscopy (time frame: From induction of anesthesia to completion of first direct laryngoscopy (intraoperative, approximately 10 minutes).). 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 2 Jan 2026.