NCT07480031Not yet recruiting
Determination of the Optimal Inspiratory Pressure to Decrease Incidence of Gastric Insufflation With Adequate Ventilation During Facemask Ventilation in Morbidly Obese Patients
Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation in Morbidly Obese Patients to Prevent Gastric Insufflation: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
The goal of this randomized clinical trial is to optimize the inspiratory pressure during facemask ventilation (FMV) in morbidly obese patients (BMI ≥40 kg/m²), to ensure adequate ventilation while minimizing the risk of gastric insufflation by real-time ultrasound guidance
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 11 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Benha University
- Diseases
- Obesity
- NCT number
- NCT07480031
What you commit to
- Study type: Interventional
- Planned participants: 144
- From 1 Apr 2026 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- • Emergency surgery (due to inability to ensure proper fasting or preoperative assessment).
- Known or suspected difficult airway (Mallampati class IV, limited neck mobility, or history of difficult intubation).
- Gastroesophageal reflux disease (GERD) or high aspiration risk (e.g., pregnancy, symptomatic hiatal hernia).
- Contraindications to facemask ventilation (facial trauma, beard/mask seal interference).
- Severe cardiopulmonary disease (e.g., severe COPD, pulmonary hypertension, or unstable angina).
- Neuromuscular disorders affecting respiratory function.
- Refusal to participate or inability to provide informed consent.
Who the study is looking for
- Adult patients (18-65 years old) scheduled for elective surgery under general anesthesia requiring facemask ventilation.
- Morbid obesity (BMI ≥40 kg/m²).
- American Society of Anesthesiologists (ASA) physical status II-III.
- Normal upper gastrointestinal anatomy (no history of gastric surgery, esophageal strictures, or hiatus hernia).
- Fasted for at least 6 hours for solids and 2 hours for fluids (standard preoperative fasting guidelines).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Benha University Hospitals Coordinator of this site? Confirm its status | Banhā | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.