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NCT Number: NCT07480031

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"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).

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.

  5. Heart rate

    Time frame: At baseline, 30, 60, 90 seconds during facemask ventilation and one minute after endotracheal tube placement

  6. Mean arterial blood pressure

    Time frame: At baseline, 30, 60, 90 seconds during facemask ventilation and one minute after endotracheal tube placement

  7. Hypoxia occurrence

    Time frame: Monitored continuously from induction of anesthesia till one minute after endotracheal intubation

  8. Aspiration events

    Time frame: Continuously monitored, intraoperatively and postoperatively (24-hour follow-up).

Study contacts

Contact information is provided by the study sponsor or research team.

alaa b mohamed, MBBCH

CONTACT

[email protected]

+201019680699 ext. +201098073650

mohamed a mustafa, MSC

CONTACT

[email protected]

+201022708985 ext. +201144616418

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation in Morbidly Obese Patients to Prevent Gastric Insufflation: A Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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