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Not yet recruitingNCT07887503Updated Oct 21, 2026

Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery

An observational study in Difficult Airway Management, sponsored by Minia University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Minia University · Observational

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
550
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Difficult Airway Management
03

In context

Lead sponsor

Minia University is the lead sponsor of 368 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Minia University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

adult population of both sex morbid obese (BMI>30) UNDERGOING emergency operatiove interference within 24 hours from decision

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
550 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Ability of SHD to predict DMV in obese population undergoing emergency operations

    predicrtion via AUC, ROC curve, PPV, NPV, sensitivity and specificity

    Time frame: 20 minutes from induction

Secondary outcomes

  1. 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

    Time frame: 20 minutes

  2. identify the independent predictors of DMV

    Multiple regression using STOP-Bang score, modified Mallampati test, upper lip bite test,

    Time frame: 20 minutes

  3. 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.

    Time frame: 29 minutes

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2027, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2026
First posted
Oct 21, 2026
StartEst.
Oct 15, 2026
Primary completionEst.
Dec 1, 2027
CompletionEst.
Dec 6, 2027
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07887503
Lead sponsor
Minia University
Responsible party
Mina Maher (Ass professor anesthesia and pain, Minia University) — Principal investigator
First posted
Oct 21, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 6, 2027 (estimated)
Last update
Oct 21, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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