Finding the ventilation pressure that prevents air from entering the esophagus during anesthesia induction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial uses an adaptive bias-coin design to identify the 90% effective ventilation pressure (EP90) that avoids esophageal insufflation during mask ventilation at anesthesia induction. Adult elective surgical patients (ASA I–III, BMI 18–28) will undergo controlled mask ventilation with stepwise pressure adjustments while ultrasound and inflation monitoring detect any air entry into the esophagus. The adaptive design adjusts pressures based on earlier patients' responses to efficiently estimate the EP90. The overall aim is to produce a more precise, personalized ventilation pressure guideline to reduce the risk of gastric aspiration during induction.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: 18-65 years, regardless of gender;
2. ASA classification: I-III;
3. Scheduled for elective general anesthesia surgery;
4. BMI: 18.0-28.0 kg/m²;
5. Preoperative fasting: Solid food \>6 hours, liquid \>2 hours;
6. Less than two from five criteria predicting difficult mask ventilation as described by Langeron et al.(Prediction of difficult mask ventilation. Anesthesiology 2000; 92:1229-36);
7. No severe underlying conditions such as heart, lung, liver, or kidney disease;
8. Signed informed consent and ability to cooperate with the study protocol.

Exclusion Criteria:

1. Pregnant or breastfeeding women;
2. History of upper gastrointestinal diseases such as gastroesophageal reflux disease, peptic ulcers, or hiatal hernia;
3. Recent (within 2 weeks) respiratory infections, chronic cough, similar symptoms, and other known or predictable respiratory system diseases;
4. Need for emergency surgery or airway obstruction after anesthesia induction requiring urgent intubation;
5. Inability to achieve adequate oxygenation during mask ventilation (e.g., SpO₂ \< 92% for 30 seconds, unresponsive to treatment);
6. History of contraindications or allergies to study medications;
7. Inability to understand the study content or refusal to cooperate;
8. Oropharyngeal or facial pathology;
9. with an indwelling gastric tube, and who had previously undergone gastric surgery.

Where it's running

• Affiliated Hospital of Jiaxing University
  Jiaxing, China Recruiting

Study contacts

• Study coordinator: Qinghe Zhou
• Email: zqh10980@zjxu.edu.edu.cn
• Phone: 13732573379

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.