Difficult Airway ManagementNCT07887503
Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery
An observational study of Difficult Airway Management, run by Minia University.
Trial summary
The current study is an observational, prospective study. It will be conducted in the emergency operative theatre, Alfayoum University, Alfayoum, Egypt. Identification of difficult mask ventilation among obese population is crucial specially in emergency settings with high risk of aspiration pneumonia or hypoxemia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Difficult Airway Management
- How many people
- 550 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 6 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult population of both sex morbid obese (BMI>30) UNDERGOING emergency operatiove interference within 24 hours from decision
Who may be able to join
- Adults aged ≥18 years. Body mass index (BMI) ≥30 kg/m², measured before induction. Patients scheduled for emergency surgical procedures under general anesthesia with planned tracheal intubation.
- Emergency surgery defined as surgery requiring operative intervention within 24 hours of the decision to operate because postponement may adversely affect the patient.
- . Availability of sufficient pre-induction time to perform the standardized ultrasound assessment without delaying clinically indicated surgery.
- Written informed consent obtained from the patient or, where applicable under the approved emergency research procedure, from an authorized representative
Who cannot join
- Elective procedures
- Patient refusal
- Previous anterior neck surgery or radiotherapy with scarring precluding good acoustic window.
- Submental trauma, abcess or surgical emphysema.
- Planned awake fibrooptic intubation
- Planned regional anesthesia
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- Inability to obtain a technically adequate ultrasound image after standardized attempts.
- Emergency C.S
- Severe hypoxemia requiring immediate assisted ventilation.
- Patients already receiving bag-mask ventilation, or invasive ventilation before the ultrasound assessment.
- -
About this study
Official title: Preoperative Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery Using Ultrasound Skin to Hyoid Bone Distance. An Observational, Multicenter, Prospective Study.
The current study is an observational, prospective study. It will be conducted in the emergency operative theatre, Alfayoum University, Alfayoum, Egypt. Identification of difficult mask ventilation among obese population is crucial specially in emergency settings with high risk of aspiration pneumonia or hypoxemia. No clinical predicrors were identified up till now. While the patient lies supine with the head in neutral position, Ultrasound guided (high frequency- depth adjusted at 3-4 cm) will be placed in the in submental region to measure the distance between skin to hyoid bone . Hyoid bone will be identified as a hyperechoic shadow below the mentum. Three measures will be taken and the average will be calculated. All candidates will sign informed consent pre-scanning and retain their right to withdraw at any time without compromising their medical care. Exclusion criteria will include elective operations, patient refual, previous neck surgery, prescence of surgical emphysema, emergency cesarean section and submental abcess.
- Conditions
- Difficult Airway Management
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of SHD to predict DMV in obese population undergoing emergency operations
predicrtion via AUC, ROC curve, PPV, NPV, sensitivity and specificity
Measured: 20 minutes from induction
Secondary outcomes (3)
comparing the ability of SHD to predict DMV with other predictors.
Multiple regression using STOP-Bang score, modified Mallampati test, upper lip bite test, and SHD
Measured: 20 minutes
identify the independent predictors of DMV
Multiple regression using STOP-Bang score, modified Mallampati test, upper lip bite test,
Measured: 20 minutes
Net Benefit of the Prediction Model for difficult mask ventilation using skin to hyoid distance
Decision curve analysis will be used to estimate the net benefit of the prediction model. Net benefit will be compared with the treat-all and treat-none strategies to evaluate the potential clinical utility of the prediction model.
Measured: 29 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion6 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Airway ManagementStudies of the same condition, open and under way.
- More trials run by Minia 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
- 550 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887503
- Sponsor's protocol ID
- R/907
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 21 Oct 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery Using Ultrasound Skin to Hyoid Bone Distance. An Observational, Multicenter, Prospective Study.
- ClinicalTrials.gov ID
- NCT07887503
- Acronym / sponsor ID
- R/907
- Conditions
- Difficult Airway Management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 6 Dec 2027 (estimated)
- First posted
- 21 Oct 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.
The current study is an observational, prospective study. It will be conducted in the emergency operative theatre, Alfayoum University, Alfayoum, Egypt. Identification of difficult mask ventilation among obese population is crucial specially in emergency settings with high risk of aspiration pneumonia or hypoxemia. No clinical predicrors were identified up till now. While the patient lies supine with the head in neutral position, Ultrasound guided (high frequency- depth adjusted at 3-4 cm) will be placed in the in submental region to measure the distance between skin to hyoid bone . Hyoid bone will be identified as a hyperechoic shadow below the mentum. Three measures will be taken and the average will be calculated. All candidates will sign informed consent pre-scanning and retain their right to withdraw at any time without compromising their medical care. Exclusion criteria will include elective operations, patient refual, previous neck surgery, prescence of surgical emphysema, emergency cesarean section and submental abcess.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult population of both sex morbid obese (BMI>30) UNDERGOING emergency operatiove interference within 24 hours from decision
Key inclusion criteria (4 listed)
- Adults aged ≥18 years. Body mass index (BMI) ≥30 kg/m², measured before induction. Patients scheduled for emergency surgical procedures under general anesthesia with planned tracheal intubation.
- Emergency surgery defined as surgery requiring operative intervention within 24 hours of the decision to operate because postponement may adversely affect the patient.
- . Availability of sufficient pre-induction time to perform the standardized ultrasound assessment without delaying clinically indicated surgery.
- Written informed consent obtained from the patient or, where applicable under the approved emergency research procedure, from an authorized representative
Key exclusion criteria (11 listed)
- Elective procedures
- Patient refusal
- Previous anterior neck surgery or radiotherapy with scarring precluding good acoustic window.
- Submental trauma, abcess or surgical emphysema.
- Planned awake fibrooptic intubation
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
Ability of SHD to predict DMV in obese population undergoing emergency operations
Time frame: 20 minutes from induction
predicrtion via AUC, ROC curve, PPV, NPV, sensitivity and specificity
3 secondary outcomes
comparing the ability of SHD to predict DMV with other predictors.
Time frame: 20 minutes
identify the independent predictors of DMV
Time frame: 20 minutes
Net Benefit of the Prediction Model for difficult mask ventilation using skin to hyoid distance
Time frame: 29 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 21 Oct 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?
An observational study of Difficult Airway Management, run by Minia 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 11 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 21 Oct 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?
Ability of SHD to predict DMV in obese population undergoing emergency operations (time frame: 20 minutes from induction). 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 21 Oct 2026.