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

ConditionGastric Insufflation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBenha University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

• 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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • "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).

Treatment groups

144 Participants
are divided into 4 treatment groups
Group A: group AExperimental treatment 1 intervention
Group B: group BExperimental treatment 1 intervention
Group C: group CExperimental treatment 1 intervention
Group D: group DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Gastric insufflation (ultrasound-confirmed) during FMV

Time frame
At 30 seconds, 60 seconds, and 90 seconds after induction

Secondary outcomes

1

Tidal volume (mL/kg ideal body weight) and peak inspiratory pressure

Time frame
at 30, 60, and 90 seconds of facemask ventilation (FMV)
2

Oxygen saturation (SpO₂)

Time frame
At baseline and 30 seconds, 60 seconds, and 90 seconds during FMV
3

End tidal CO2

Time frame
At baseline and 30 seconds, 60 seconds, and 90 seconds during FMV
4

Antral cross-sectional area

Time frame
at baseline (15 minutes before induction) and 30, 60, 90 seconds during FMV.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: