NCT07340255

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

The 90% Effective Ventilation Pressure (EP90) for Esophageal Insufflation Avoidance During Anesthesia Induction: A Bias-Coin Design With Up-and-Down Sequential Allocation Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Affiliated Hospital of Jiaxing University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pulmonary aspiration of gastric contents has been identified as one of the leading causes of anesthesia-related mortality. Even in fasting patients or those without known aspiration risks, such complications can still occur. In fact, in patients with unprotected airways during apnea, the introduction of air into the lungs during ventilation may become a potential trigger for gastric content aspiration. The entry of air can increase gastric pressure, leading to the reflux of gastric contents into the esophagus, which may subsequently result in hemodynamic instability and pulmonary failure. Therefore, airway management during anesthesia induction is crucial, particularly in the precise control of ventilation pressure, as it directly impacts the safety of the patient during surgery. Previous studies have used gastric insufflation as the primary endpoint for evaluating the safety of ventilation pressures, often assessing the appearance of gastric gas in the stomach during mask ventilation. However, gastric insufflation typically occurs only after gas has passed through the esophagus and cardia, entering the gastric cavity-this process is a "terminal event" triggered by higher pressures. The esophagus, being structurally weaker than the stomach, is less tolerant to pressure. When gas first enters the esophagus, the cardia is not fully open, and if ventilation pressure continues to rise, it is easy to cause esophageal insufflation, further leading to gastric insufflation and even gastric content reflux. Since esophageal insufflation occurs earlier and has a lower pressure threshold, it can serve as a more sensitive indicator, providing an early warning to anesthesiologists about potential airway management issues. To address this issue, determining the optimal ventilation pressure to avoid esophageal insufflation is particularly important. the 90% effective ventilation pressure (EP90) refers to the ventilation pressure that can avoid esophageal insufflation in 90% of cases, providing anesthesiologists with a quantitative reference for ventilation pressures. This study employed a Sequential Allocation with Biased Coin Design (SABCD) trial, utilizing precise statistical methods to explore the EP90 for avoiding esophageal insufflation during anesthesia induction. The goal was to determine the optimal ventilation pressure for preventing esophageal insufflation during anesthesia induction and to explore its implications for anesthesia management. The ultimate aim 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

Interventions

Type	Name	Description
OTHER	Ultrasonic and inflation determination	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.

Timeline

• Start date: 2025-09-29
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: China