Gastric InsufflationNCT07480031
Determination of the Optimal Inspiratory Pressure to Decrease Incidence of Gastric Insufflation With Adequate Ventilation During Facemask Ventilation in Morbidly Obese Patients
A study testing "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation" in people with Gastric Insufflation, run by Benha University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastric Insufflation
- What is being tested?
- "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Benha University Hospitals
Banhā
nasser k el-gizawy, MD, 0020133231011 ext. 0020133231012, info@bu.edu.eg
About this study
Official title: Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation in Morbidly Obese Patients to Prevent Gastric Insufflation: A Randomized Clinical 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
Read the detailed description
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.
- Conditions
- Gastric Insufflation
- Being tested
- "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"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).
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | This arm will be subjected to inspiratory pressure 10 cmH₂O Receives: Device: "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation" |
| group B | Experimental | This arm will be subjected to inspiratory pressure 15 cmH₂O Receives: Device: "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation" |
| group C | Experimental | This arm will be subjected to inspiratory pressure 20 cmH₂O Receives: Device: "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation" |
| group D | Experimental | This arm will be subjected to inspiratory pressure 25 cmH₂O Receives: Device: "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Gastric insufflation (ultrasound-confirmed) during FMV
Measured: At 30 seconds, 60 seconds, and 90 seconds after induction
Secondary outcomes (8)
Tidal volume (mL/kg ideal body weight) and peak inspiratory pressure
Measured: at 30, 60, and 90 seconds of facemask ventilation (FMV)
Oxygen saturation (SpO₂)
Measured: At baseline and 30 seconds, 60 seconds, and 90 seconds during FMV
End tidal CO2
Measured: At baseline and 30 seconds, 60 seconds, and 90 seconds during FMV
Antral cross-sectional area
Measured: at baseline (15 minutes before induction) and 30, 60, 90 seconds during FMV.
Heart rate
Measured: At baseline, 30, 60, 90 seconds during facemask ventilation and one minute after endotracheal tube placement
Mean arterial blood pressure
Measured: At baseline, 30, 60, 90 seconds during facemask ventilation and one minute after endotracheal tube placement
Hypoxia occurrence
Measured: Monitored continuously from induction of anesthesia till one minute after endotracheal intubation
Aspiration events
Measured: Continuously monitored, intraoperatively and postoperatively (24-hour follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric InsufflationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- •"Face mask ventilation with isoflurane for 90 seconds assisted by oropharyngeal or nasopharyngeal airway before endotracheal intubation. The inspiratory pressure will be adjusted according to the 4 groups at (10-15-20-25 cmH₂O) and set on the anesthesia ventilator (PEEP = 5 cmH₂O). Ventilation will be pressure-controlled with FiO₂ 100%, RR = 14 breaths/min, I:E = 1:2. The study inspiratory pressure refers to the set inspiratory pressure above PEEP (i.e., set PIP). 1. A curvilinear ultrasound probe (2-5 MHz) will be placed in the epigastric region to visualize the antrum. 2. Baseline gastric ultrasound will be performed to confirm an empty stomach (cross-sectional area of the antrum \<3.4 cm²). 3. During FMV, ultrasound images will be obtained at 30 s, 60 s, and 90 s. Gastric insufflation is defined as any of the following: Appearance of air artifacts ("comet tail" or "ring-down" artifacts). Increase in antral cross-sectional area ≥3.4 cm². ΔCSA (cross-sectional area) \>30%."
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed abd-elrazik mustafa mansour mohamed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480031
- Sponsor's protocol ID
- 3.7.2025
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation in Morbidly Obese Patients to Prevent Gastric Insufflation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07480031
- Acronym / sponsor ID
- 3.7.2025
- Conditions
- Gastric Insufflation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- •"Face mask ventilation with isoflurane for 90 seconds assisted by oropharyngeal or nasopharyngeal airway before endotracheal intubation. The inspiratory pressure will be adjusted according to the 4 groups at (10-15-20-25 cmH₂O) and set on the anesthesia ventilator (PEEP = 5 cmH₂O). Ventilation will be pressure-controlled with FiO₂ 100%, RR = 14 breaths/min, I:E = 1:2. The study inspiratory pressure refers to the set inspiratory pressure above PEEP (i.e., set PIP). 1. A curvilinear ultrasound probe (2-5 MHz) will be placed in the epigastric region to visualize the antrum. 2. Baseline gastric ultrasound will be performed to confirm an empty stomach (cross-sectional area of the antrum <3.4 cm²). 3. During FMV, ultrasound images will be obtained at 30 s, 60 s, and 90 s. Gastric insufflation is defined as any of the following: Appearance of air artifacts ("comet tail" or "ring-down" artifacts). Increase in antral cross-sectional area ≥3.4 cm². ΔCSA (cross-sectional area) >30%."
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Device: "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation"This arm will be subjected to inspiratory pressure 10 cmH₂O |
| group B | Experimental | Device: "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation"This arm will be subjected to inspiratory pressure 15 cmH₂O |
| group C | Experimental | Device: "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation"This arm will be subjected to inspiratory pressure 20 cmH₂O |
| group D | Experimental | Device: "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation"This arm will be subjected to inspiratory pressure 25 cmH₂O |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (18-65 years old) scheduled for elective surgery under general anesthesia requiring facemask ventilation.
Key exclusion criteria (7 listed)
- • Emergency surgery (due to inability to ensure proper fasting or preoperative assessment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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). | Device | group A |
| "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). | Device | group B |
| "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). | Device | group C |
| "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). | Device | group D |
Primary outcome
Incidence of Gastric insufflation (ultrasound-confirmed) during FMV
Time frame: At 30 seconds, 60 seconds, and 90 seconds after induction
8 secondary outcomes
Tidal volume (mL/kg ideal body weight) and peak inspiratory pressure
Time frame: at 30, 60, and 90 seconds of facemask ventilation (FMV)
Oxygen saturation (SpO₂)
Time frame: At baseline and 30 seconds, 60 seconds, and 90 seconds during FMV
End tidal CO2
Time frame: At baseline and 30 seconds, 60 seconds, and 90 seconds during FMV
Antral cross-sectional area
Time frame: at baseline (15 minutes before induction) and 30, 60, 90 seconds during FMV.
Heart rate
Time frame: At baseline, 30, 60, 90 seconds during facemask ventilation and one minute after endotracheal tube placement
Mean arterial blood pressure
Time frame: At baseline, 30, 60, 90 seconds during facemask ventilation and one minute after endotracheal tube placement
Hypoxia occurrence
Time frame: Monitored continuously from induction of anesthesia till one minute after endotracheal intubation
Aspiration events
Time frame: Continuously monitored, intraoperatively and postoperatively (24-hour follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Ultrasound-Guided Optimization of Inspiratory Pressure During Facemask Ventilation" in people with Gastric Insufflation, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mohamed a mustafa, MSC (+201022708985 ext. +201144616418, mhmdabdelrazik248@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Gastric insufflation (ultrasound-confirmed) during FMV (time frame: At 30 seconds, 60 seconds, and 90 seconds after induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.