The 90% Effective Ventilation Pressure (EP90) for Esophageal Insufflation Avoidance During Anesthesia Induction

NCT07340255 | Recruiting DMC

• 1 other identifier: 2025-KY-396
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Exploring the 90% Effective Ventilation Pressure (EP90) for Esophageal Insufflation Avoidance During Anesthesia Induction: The aim is to determine the optimal ventilation pressure for esophageal insufflation avoidance during anesthesia induction and to explore its guiding significance for anesthesia management. The goal is to provide a more precise and personalized ventilation pressure setting standard for clinical anesthesia, thereby enhancing the safety of the anesthesia induction phase.

Conditions

Airway Management; Induction of Anesthesia

Keywords

Esophageal Insufflation; Airway Management; Ventilation; Bias-coin Design

Outcome Measures

Primary Outcomes (1)

• EP90

  The 90% effective ventilation pressure (EP90) for avoiding esophageal inflation refers to the minimum effective airway pressure (measured in cmH₂O) at which 90% of patients do not experience esophageal inflation during pressure-controlled mask ventilation during anesthesia induction.

  Perioperative

Secondary Outcomes (9)

• EP95

  Periprocedural

• EP98

  Periprocedural

• Ventilation-related respiratory parameters

  Periprocedural

• Ventilation-related respiratory parameters

  Periprocedural

• Ventilation-related respiratory parameters

  Periprocedural

Study Arms (1)

Ventilation Pressure

EXPERIMENTAL

Anesthesia machine settings: pressure control mode, inspiratory-to-expiratory ratio of 1:2, respiratory rate of 15 breaths/min, 100% oxygen, no PEEP applied. Mask ventilation duration was standardized to 120 seconds, followed by tracheal intubation.

Other: Ultrasonic and inflation determination

Interventions

Ultrasonic and inflation determination OTHER

Before induction, during ventilation, and after intubation, the anesthesiologist used a 7-14 MHz linear array probe for transverse (supraclavicular) positioning to monitor the left paratracheal esophageal region in real time. The main criterion for assessment was the absence of esophageal gas during ventilation, which was considered a positive response. If gas was detected entering the esophagus on ultrasound, it was recorded as a negative response. Additionally, the anesthesiologist performed a preoperative ultrasound examination of the gastric antrum to record baseline gastric antrum parameters. After successful tracheal intubation, a follow-up ultrasound of the gastric antrum was conducted to obtain postoperative gastric antrum parameters.

Ventilation Pressure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years, regardless of gender;
• ASA classification: I-III;
• Scheduled for elective general anesthesia surgery;
• BMI: 18.0-28.0 kg/m²;
• Preoperative fasting: Solid food \>6 hours, liquid \>2 hours;
• 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);
• No severe underlying conditions such as heart, lung, liver, or kidney disease;
• Signed informed consent and ability to cooperate with the study protocol.

You may not qualify if:

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

Sponsors & Collaborators

• Affiliated Hospital of Jiaxing University: lead

Study Sites (1)

Affiliated Hospital of Jiaxing University

Jiaxing, China

RECRUITING

Related Publications (1)

• Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009.

  PMID: 10781266 RESULT

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Qinghe Zhou, Dr.

  Affiliated Hospital of Jiaxing University

  STUDY CHAIR

Central Study Contacts

Qinghe Zhou

CONTACT

13732573379; zqh10980@zjxu.edu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Anesthesiology

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: January 14, 2026
• Study Start: September 29, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)