Ultrasound-Guided Esophageal Compression During Adult Mask Ventilation

NCT06688097 | Completed DMC

• 1 other identifier: KY20240924-01
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 103 elective surgery patients who met the inclusion criteria were selected. After screening for eligibility according to the inclusion and exclusion criteria and signing informed consent, they were randomly divided into two groups. Upon entering the operating room, routine ECG monitoring was initiated, and a peripheral vein was opened. Ultrasound was used to measure the baseline cross-sectional area (CSA) of the gastric antrum in the supine position. After general anesthesia induction, positive pressure ventilation was applied via face mask. Group A received no external compression, while Group B underwent esophageal compression under ultrasound guidance.

Conditions

Laparoscopic Surgery; Ultrasonography; Compression of Esophagus; Stomach Distended

Outcome Measures

Primary Outcomes (1)

• The incidence of gastric distension

  Defined as a significant increase in gastric antrum CSA with acoustic shadowing or the characteristic "comet-tail sign," or when the enlarged gastric antrum obstructs the surgical field

  During anesthesia induction

Secondary Outcomes (8)

• The positional relationship between the esophagus and trachea

  Before anesthesia induction

• Tidal volume

  During anesthesia induction

• Oxygen saturation

  During anesthesia induction

• Airway plateau

  During anesthesia induction

• The percentage of glottic opening (POGO) score

  During tracheal intubation, immediately

Study Arms (2)

Group A (Control Group)

NO INTERVENTION

No esophageal compression is applied, and FMV is performed for 4 minutes.

Group B (Intervention Group)

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.

Behavioral: Compression of esophageal

Interventions

Compression of esophageal BEHAVIORAL

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.

Group B (Intervention Group)

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 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.
• Patients scheduled for laparoscopic surgery.
• Fasting for ≥8 hours and abstaining from liquids for ≥2 hours before surgery, with low risk of gastroesophageal regurgitation and aspiration.

You may not qualify if:

• 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.
• Patients requiring non-invasive ventilation prior to surgery.
• Patients currently participating in other clinical trials or who refuse to participate.

Sponsors & Collaborators

• Liu Han: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Gastric Dilatation

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Anesthesia, Pain and Perioperative Medicine

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: November 14, 2024
• Study Start: September 25, 2024
• Primary Completion: September 12, 2025
• Study Completion: December 31, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)