Determination of the Optimal Inspiratory Pressure to Decrease Incidence of Gastric Insufflation W… (NCT07480031) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Determination of the Optimal Inspiratory Pressure to Decrease Incidence of Gastric Insufflation With Adequate Ventilation During Facemask Ventilation in Morbidly Obese Patients
Egypt144 participantsStarted 2026-04-01
Plain-language summary
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
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* • 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.
What they're measuring
1
Incidence of Gastric insufflation (ultrasound-confirmed) during FMV
Timeframe: At 30 seconds, 60 seconds, and 90 seconds after induction