Laparoscopic SurgeryNCT06688097
Ultrasound-Guided Esophageal Compression During Adult Mask Ventilation
A study testing Compression of esophageal in people with Laparoscopic Surgery and Ultrasonography, run by Liu Han at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Surgery, Ultrasonography, Compression of Esophagus
- What is being tested?
- Compression of esophageal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Esophageal Compression During Adult Mask Ventilation: A Prospective Observational Study
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.
Read the detailed description
Upon entering the operating room, intravenous access is established, and oxygen is administered. Standard vital sign monitoring is initiated, including heart rate, non-invasive blood pressure, peripheral oxygen saturation, temperature monitoring, and BIS monitoring. Ultrasound is used to measure the cross-sectional area (CSA) of the gastric antrum before the onset of FMV.
Oxygen is administered via face mask for denitrogenation, with 100% pure oxygen (6 L/min flow rate). Intravenous medications are sequentially administered: midazolam 0.03 mg/kg, propofol 1-2 mg/kg, sufentanil 0.5 μg/kg, remifentanil 1 μg/kg, and rocuronium bromide 0.6 mg/kg. After the patient loses consciousness and the eyelash reflex is absent, FMV is initiated. The trial employs a pressure-controlled ventilation (PCV) mode with a pressure of 18 cmH2O, a level sufficient to provide adequate alveolar ventilation while staying below the threshold for significant gastroesophageal regurgitation. The respiratory rate is set at 14 breaths per minute with an inspiration-to-expiration ratio of 1:2.
After three minutes of FMV, the gastric antrum CSA is measured again in supine, semi-recumbent, and right lateral decubitus positions. Video laryngoscopy is used to record POGO scores before and after ultrasound-guided esophageal compression, and after 4 minutes of ventilation, tracheal intubation is performed. Grouping:
Group A (Control Group): No esophageal compression is applied, and FMV is performed for 4 minutes.
Group B (Intervention Group): 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.
- Being tested
- Compression of esophageal
- Medical subject headings
- Gastric Dilatation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression of esophagealBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Compression of esophageal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During anesthesia induction
Secondary outcomes (8)
The positional relationship between the esophagus and trachea
Observe the position of the esophagus relative to the trachea without the application of pressure on the patient, and assess whether there is any positional change of the esophagus relative to the trachea under ultrasound guidance after esophageal compression, ensuring the accuracy and safety of esophageal compression.
Measured: Before anesthesia induction
Tidal volume
Observe whether tidal volume is affected after ultrasound-guided esophageal compression and evaluate the impact of esophageal compression on ventilation quality. Effective esophageal compression should maintain a tidal volume of no less than 6 ml/kg for the patient.
Measured: During anesthesia induction
Oxygen saturation
Observe whether oxygen saturation is affected after ultrasound-guided esophageal compression and evaluate the impact of esophageal compression on ventilation quality. Effective esophageal compression should maintain the patient's oxygen saturation at no less than 95%.
Measured: During anesthesia induction
Airway plateau
Observe the values of airway plateau pressure during esophageal compression to evaluate the mechanical impact of esophageal compression on the airway. An airway plateau pressure not exceeding 20-25 cmH₂O indicates effective esophageal compression.
Measured: During anesthesia induction
The percentage of glottic opening (POGO) score
The percentage of glottic opening (POGO) score represents the portion of the glottis visualized. It is defined anteriorly by the anterior commissure and posteriorly by the interarytenoid notch. The score ranges from 0% when none of the glottis is seen to 100% when the entire glottis including the anterior commissure is seen.
A POGO score of 100% denotes visualization of the entire glottic opening in linear fashion from the anterior commissure to the posterior cartilages . If none of the glottic opening is seen, then the POGO score is 0%. The higher the POGO value, the less impact effective esophageal compression has on ventilation performance.
Measured: During tracheal intubation, immediately
Surgeon's evaluation of gastric insufflation
The degree of gastric distention is assessed by the same surgeon through laparoscopy. A score of 0 is given when there is no significant gastric distention, a score of 1 is given when there is noticeable gastric distention that does not affect the surgical procedure, and a score of 2 is given when there is significant gastric distention that affects the surgery, requiring the placement of a gastric tube for decompression. The number of postoperative vomiting episodes is recorded: 0 episodes is scored as 0, 1-2 episodes is scored as 1, and more than 2 episodes is scored as 2. A lower score indicates better esophageal compression effectiveness.
Measured: Upon the start of surgery, immediately
Rate of esophageal diameter change
Compare the diameter before and after esophageal compression and calculate the percentage change in diameter. After esophageal compression, the diameter of the esophagus should decrease. The percentage change in diameter is usually expressed as a negative value, indicating that the esophagus has constricted after compression. If the percentage change is positive, it suggests that the compression effect is not ideal, and the esophagus may not have been effectively compressed.
Measured: During anesthesia induction
Esophageal compression pressure
Recording esophageal compression pressure can ensure that the applied pressure is within an effective range, help understand the relationship between compression intensity and ventilation efficacy, and promptly identify potential complications, such as airway compression or esophageal injury caused by excessive pressure, allowing for necessary interventions.
Measured: During anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start25 Sep 2024
- Primary completion12 Sep 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liu Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Han, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688097
- Sponsor's protocol ID
- KY20240924-01
- Status last verified
- Apr 2026
- First submitted
- 15 Oct 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Esophageal Compression During Adult Mask Ventilation: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06688097
- Acronym / sponsor ID
- KY20240924-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Liu HanUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Upon entering the operating room, intravenous access is established, and oxygen is administered. Standard vital sign monitoring is initiated, including heart rate, non-invasive blood pressure, peripheral oxygen saturation, temperature monitoring, and BIS monitoring. Ultrasound is used to measure the cross-sectional area (CSA) of the gastric antrum before the onset of FMV.
Oxygen is administered via face mask for denitrogenation, with 100% pure oxygen (6 L/min flow rate). Intravenous medications are sequentially administered: midazolam 0.03 mg/kg, propofol 1-2 mg/kg, sufentanil 0.5 μg/kg, remifentanil 1 μg/kg, and rocuronium bromide 0.6 mg/kg. After the patient loses consciousness and the eyelash reflex is absent, FMV is initiated. The trial employs a pressure-controlled ventilation (PCV) mode with a pressure of 18 cmH2O, a level sufficient to provide adequate alveolar ventilation while staying below the threshold for significant gastroesophageal regurgitation. The respiratory rate is set at 14 breaths per minute with an inspiration-to-expiration ratio of 1:2.
After three minutes of FMV, the gastric antrum CSA is measured again in supine, semi-recumbent, and right lateral decubitus positions. Video laryngoscopy is used to record POGO scores before and after ultrasound-guided esophageal compression, and after 4 minutes of ventilation, tracheal intubation is performed. Grouping:
Group A (Control Group): No esophageal compression is applied, and FMV is performed for 4 minutes.
Group B (Intervention Group): 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Control Group) | No intervention | –No esophageal compression is applied, and FMV is performed for 4 minutes. |
| Group B (Intervention Group) | Experimental | Behavioral: Compression of esophagealUltrasound-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression of esophagealBefore 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. | Behavioural | Group B (Intervention Group) |
Primary outcome
The incidence of gastric distension
Time frame: During anesthesia induction
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
8 secondary outcomes
The positional relationship between the esophagus and trachea
Time frame: Before anesthesia induction
Tidal volume
Time frame: During anesthesia induction
Oxygen saturation
Time frame: During anesthesia induction
Airway plateau
Time frame: During anesthesia induction
The percentage of glottic opening (POGO) score
Time frame: During tracheal intubation, immediately
Surgeon's evaluation of gastric insufflation
Time frame: Upon the start of surgery, immediately
Rate of esophageal diameter change
Time frame: During anesthesia induction
Esophageal compression pressure
Time frame: During anesthesia induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression of esophageal in people with Laparoscopic Surgery and Ultrasonography, run by Liu Han at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of gastric distension (time frame: During anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.