Clinical trial

Determination of the Optimal Inspiratory Pressure to Decrease Incidence of Gastric Insufflation With Adequate Ventilation During Facemask Ventilation in Morbidly Obese Patients

Opening soon · Not applicable · 1 countries · Registry ID NCT07480031

Opening soonNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionGastric Insufflation

Full registry criteria

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.

Treatments and study arms

"Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation"

Device

Description: Group A will be subjected to an inspiratory pressure of 10 cmH₂O. A curvilinear ultrasound probe will be placed in the epigastric region to visualize the antrum. Baseline gastric ultrasound will be performed to confirm an empty stomach. During FMV, ultrasound images will be obtained at 30, 60, and 90 seconds. Gastric insufflation will be detected by the change in gastric cross-sectional area (ΔCSA).

"Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation"

Device

Description: Group B will be subjected to an inspiratory pressure of 15 cmH₂O. A curvilinear ultrasound probe will be placed in the epigastric region to visualize the antrum. Baseline gastric ultrasound will be performed to confirm an empty stomach. During FMV, ultrasound images will be obtained at 30, 60, and 90 seconds. Gastric insufflation will be detected by the change in gastric cross-sectional area (ΔCSA).

"Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation"

Device

Description: Group C will be subjected to an inspiratory pressure of 20 cmH₂O. A curvilinear ultrasound probe will be placed in the epigastric region to visualize the antrum. Baseline gastric ultrasound will be performed to confirm an empty stomach. During FMV, ultrasound images will be obtained at 30, 60, and 90 seconds. Gastric insufflation will be detected by the change in gastric cross-sectional area (ΔCSA).

"Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation"

Device

Description: Group D will be subjected to an inspiratory pressure of 25 cmH₂O. A curvilinear ultrasound probe will be placed in the epigastric region to visualize the antrum. Baseline gastric ultrasound will be performed to confirm an empty stomach. During FMV, ultrasound images will be obtained at 30, 60, and 90 seconds. Gastric insufflation will be detected by the change in gastric cross-sectional area (ΔCSA).

Primary outcomes

Incidence of Gastric insufflation (ultrasound-confirmed) during FMVAt 30 seconds, 60 seconds, and 90 seconds after induction

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Benha University Hospitals🇪🇬 Banhā, Egypt
nasser k el-gizawy, MDContact