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Clinical Trials in Egypt / NCT07480031
Starting soon Not applicable

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

NCT07480031 · tracked via the Priya Life Science Egypt tracker
Sponsor
Benha University
Phase
Not applicable
Started
2026-04-01
Last updated
2026-03-18

Condition(s) studied

Gastric Insufflation

Investigational drug(s) / intervention(s)

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

"Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation": 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": 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": 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": 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).

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of Gastric insufflation (ultrasound-confirmed) during FMV — At 30 seconds, 60 seconds, and 90 seconds after induction

Trial sites (1)

FacilityCityRegionStatus
Benha University Hospitals Banhā Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07480031 on ClinicalTrials.gov ↗ ← All trials in Egypt