Suspended

Ultrasound-Guided Esophageal Compression During Mask Ventilation in Adults

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Compression of esophageal

Behavioral
Who is being recruted

Digestive System Diseases+1

+ Gastrointestinal Diseases

+ Gastric Dilatation

From 18 to 65 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: September 2024
See protocol details

Summary

Principal SponsorLiu Han
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 25, 2024

Actual date on which the first participant was enrolled.

This clinical study aims to explore a new method for improving mask ventilation in adults during surgery. It focuses on using ultrasound to guide esophageal compression, which could potentially reduce the risk of stomach contents entering the lungs during ventilation. The study involves adult patients who are undergoing surgery and require ventilation with a face mask. The main goal is to see if applying pressure to the esophagus can enhance the effectiveness of mask ventilation, thereby improving patient safety during surgical procedures. Participants in the study receive oxygen through a face mask and a series of medications to induce unconsciousness. The study involves two groups: one receives the standard mask ventilation, while the other has ultrasound-guided pressure applied to the esophagus during ventilation. The size of the stomach is measured using ultrasound before and after ventilation to assess any changes. The study carefully monitors vital signs and uses video laryngoscopy to record the ease of intubation. This process helps evaluate the effectiveness of the esophageal compression technique in maintaining clear airways and preventing regurgitation during surgery.

Official TitleUltrasound-Guided Esophageal Compression During Adult Mask Ventilation: A Prospective Observational Study
NCT06688097
Principal SponsorLiu Han
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

103 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastrointestinal DiseasesGastric DilatationStomach Diseases

Criteria

6 inclusion criteria required to participate
Age 18 to 65 years

American Society of Anesthesiologists (ASA) Physical Status Classification I-II.

Body Mass Index (BMI) between 18 and 28 kg/m².

Patients undergoing elective tracheal intubation for general anesthesia.

Show More Criteria

6 exclusion criteria prevent from participating
Suspected difficult FMV (e.g., age >55 years, BMI >26 kg/m², edentulous, history of snoring, and long beard; presence of two or more factors).

Pre-existing respiratory, pharyngeal, laryngeal, facial, or neck pathology.

History of gastrointestinal surgery, gastroesophageal reflux disease (GERD), or high risk of aspiration.

Severe cardiac, cerebral, pulmonary, hepatic, or renal diseases.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Ultrasound-guided esophageal compression plus FMV: before the start of FMV, ultrasound is used to locate the esophagus, and pressure is applied to the esophagus at the cricoid level to collapse the esophageal lumen. Esophageal pressure is released just before tracheal intubation following 4 minutes of ventilation.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Nanjing First Hospital

Nanjing, ChinaOpen Nanjing First Hospital in Google Maps
SuspendedOne Study Center