Benha University Hospitals
Banhā, Egypt
NCT Number: NCT07480031
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
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Banhā, Egypt
Morbid obesity, defined as a body mass index (BMI) ≥ 40 kg/m², presents significant challenges during the management of the airway and ventilation under general anesthesia. One of the critical issues is the increased risk of gastric insufflation during facemask ventilation (FMV), which can lead to pulmonary aspiration, reduced lung compliance, and impaired oxygenation. Therefore, optimizing inspiratory pressure to ensure adequate ventilation while minimizing the risk of gastric insufflation is paramount in this population.
Ultrasound imaging has emerged as a valuable, non-invasive tool for real-time assessment of gastric content and volume. Recent studies have demonstrated the utility of gastric ultrasonography in detecting gastric insufflation during positive pressure ventilation. By visualizing the antrum and measuring the cross-sectional area , anesthesiologists can identify even small volumes of air entering the stomach, which might not be clinically apparent.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: At 30 seconds, 60 seconds, and 90 seconds after induction
Time frame: at 30, 60, and 90 seconds of facemask ventilation (FMV)
Time frame: At baseline and 30 seconds, 60 seconds, and 90 seconds during FMV
Time frame: At baseline and 30 seconds, 60 seconds, and 90 seconds during FMV
Time frame: at baseline (15 minutes before induction) and 30, 60, 90 seconds during FMV.
Time frame: At baseline, 30, 60, 90 seconds during facemask ventilation and one minute after endotracheal tube placement
Time frame: At baseline, 30, 60, 90 seconds during facemask ventilation and one minute after endotracheal tube placement
Time frame: Monitored continuously from induction of anesthesia till one minute after endotracheal intubation
Time frame: Continuously monitored, intraoperatively and postoperatively (24-hour follow-up).
Contact information is provided by the study sponsor or research team.
alaa b mohamed, MBBCH
CONTACT
+201019680699 ext. +201098073650
mohamed a mustafa, MSC
CONTACT
+201022708985 ext. +201144616418
Benha University
Other
Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation in Morbidly Obese Patients to Prevent Gastric Insufflation: A Randomized Clinical Trial
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