Gastric VolumeNCT06861569
Effect of Positive End-expiratory Pressure on the Gastric Volume
A study testing Positive end expiratory pressure in people with Gastric Volume and Breast Cancer Female, run by Seoul National University Bundang Hospital.
Trial summary
The main purpose of this study is to quantitatively evaluate the effect of applying PEEP during the use of SGA on gastric volume, aiming to provide objective evidence regarding the potential side effects, such as gastric volume increase. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Volume, Breast Cancer Female, Anesthesia Complication
- What is being tested?
- Positive end expiratory pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 2 Feb 2026
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 19 and above.
- Patients scheduled for general anesthesia for elective surgery.
- American society of anesthesiologists physical status classification 1 or 2
Who cannot join
- Individuals who have not provided prior consent for participation in the study
- Patients showing cognitive impairment to the extent that voluntary consent is difficult
- Obesity with a BMI of 30 kg/m² or higher
- Patients with anatomical abnormalities in the airway structure making supraglottic airway device application difficult
- Patients with respiratory diseases making PEEP application difficult (e.g., chronic obstructive pulmonary disease, asthma)
- Patients suspected of delayed gastric emptying (e.g., not adhering to fasting guidelines, medication use affecting gastric motility [anticholinergics, narcotic analgesics], neurological disorders [Parkinson's disease, multiple sclerosis], diabetes, hypothyroidism)
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- Patients with a history of gastrointestinal surgery
- Pregnant women
- Patients undergoing concurrent surgeries or collaborative procedures
- Patients transferred from the intensive care unit
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Positive End-expiratory Pressure on the Gastric Volume in Patients Undergoing General Anesthesia with Supraglottic Airway Device: a Prospective Randomized Controlled Non-inferiority Trial
The main purpose of this study is to quantitatively evaluate the effect of applying PEEP during the use of SGA on gastric volume, aiming to provide objective evidence regarding the potential side effects, such as gastric volume increase. It is expected that this will contribute to improving the quality of patient management through the safe clinical use of SGA and PEEP.
Read the detailed description
General anesthesia has positive effects in relieving pain and unpleasant memories during surgery by blocking the patient's voluntary movements and reflexes to stimuli. However, it can lead to side effects such as severe impairment or absence of spontaneous breathing, necessitating artificial respiration. Among the conventional airway management methods for artificial respiration, the supraglottic airway device (SGA) has the advantage of reducing hemodynamic changes, intracranial pressure, and intraocular pressure caused by airway stimulation, as it does not pass through the airway, and it reduces airway-related complications. However, a disadvantage is its inability to adequately seal the airway, making it difficult to use in cases where there is a high risk of aspiration or when high airway pressures are required.
Positive End Expiratory Pressure (PEEP) has the advantage of preventing atelectasis, improving oxygen exchange capacity, and preventing pulmonary complications by maintaining lung expansion. However, applying PEEP increases airway pressure, and if the SGA does not adequately seal the airway, there is a possibility of air entering the stomach. If air enters the stomach and increases gastric volume, the risk of postoperative vomiting and aspiration pneumonia increases due to increased gastric pressure. Also, increased intra-abdominal pressure and diaphragmatic elevation can lead to respiratory distress due to decreased lung volume during postoperative recovery.
While there are studies suggesting that PEEP can be safely used with SGA, there is a need for verification as there are no studies objectively measuring changes in gastric volume using methods such as ultrasound when using PEEP with SGA. The main purpose of this study is to quantitatively evaluate the effect of applying PEEP during the use of SGA on gastric volume, aiming to provide objective evidence regarding the potential side effects, such as gastric volume increase. It is expected that this will contribute to improving the quality of patient management through the safe clinical use of SGA and PEEP.
Before entering the operating room, patients will be placed in a sitting and right lateral decubitus (RLD) position to measure the cross sectional area(CSA) of the stomach antrum using ultrasound. One investigator will scan the sagittal plane in the upper abdominal region using a low-frequency ultrasound probe (2-5 MHz) and measure the major diameter (D1) and transverse diameter (D2) of the observed antrum. CSA can be calculated from the measured values as in formula (a) below. The investigator will scan three times for each posture, and calculate the average.
CSA = D1 x D2 x 1/4 ------- (a) Using CSA, gastric volume (GV) is estimated using formula (b) below. GV (ml) = 27.0 + 14.6 × CSA - 1.28×age ------- (b) Midazolam premedication is not administered before surgery. When patients enter the operating room, standard monitoring devices (electrocardiogram, pulse oximetry, non-invasive blood pressure monitor, BIS or SedLine) are attached for vital sign monitoring, and target-controlled infusion of propofol is initiated at a target concentration of 4.0 µg/ml, and remifentanil at a target concentration of 3.0 ng/ml.
After confirming loss of consciousness and loss of spontaneous respiration, SGA is inserted, and the position of the SGA is evaluated and recorded using the fiberoptic scoring system.
During surgery, maintenance of anesthesia is managed with target-controlled infusion of propofol to keep BIS (Bispectral Index) between 40-60 or PSI (Patient State Index) between 25-49. For adequate analgesia during surgery, remifentanil is continuously infused using target-controlled infusion.
At 5 minutes (T0), 30 minutes (T1), and 60 minutes (T2) after SGA insertion, the following values related to mechanical ventilation are measured: FiO2 (Fraction of Inspired Oxygen), PIP (Peak Inspiratory Pressure), RR (Respiratory Rate), lung compliance, SpO2 (Oxygen Saturation), EtCO2 (End-tidal Carbon Dioxide), TV (Tidal Volume), OLP (Oropharyngeal Leak Pressure), leak volume, and leak fraction.
Immediately after surgery, CSAright-lat and GV are measured as described in above. After confirming that respiration and consciousness levels have returned to clinically normal conditions post-surgery, the patient is discharged to the recovery room, and assessments are made for nausea or vomiting, respiratory depression, sore throat, and blood staining.
- Being tested
- Positive end expiratory pressure
- Keywords
- Supraglottic Airway Device, Postive End Expiratory Pressure, Gastric Sonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive end expiratory pressureProcedure or surgery
Positive end-expiratory pressure (PEEP) is a value that can be set up in patients receiving invasive or non-invasive mechanical ventilation. 5cmH2O PEEP will be applied to the PEEP group participants.
| Study group | Role | What they receive |
|---|---|---|
| ZEEP | No intervention | Patients undergoing general anesthesia using supraglottic airway device without PEEP. |
| PEEP | Experimental | Patients undergoing general anesthesia using supraglottic airway device with PEEP of 5cmH2O. Receives: Procedure: Positive end expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric volume difference before and after surgery
Before and after the surgery, the patient is positioned in a sitting position and then in the right lateral decubitus (RLD) position. Ultrasound is used to measure the cross-sectional area (CSA) of the gastric antrum and then it is substituted into the following equation to estimate gastric volume.
GV (ml) = 27.0 + 14.6 × CSAright-lat - 1.28×age The scanning is performed three times for each position to obtain the average value.
Measured: Baseline and end of surgery 0 minute
Secondary outcomes (14)
Fraction of Inspired Oxygen
The measured values during mechanical ventilation are averaged.
Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Peak Inspiratory pressure
The measured values during mechanical ventilation are averaged.
Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Respiratory rate
The measured values during mechanical ventilation are averaged.
Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Lung compliance
The measured values during mechanical ventilation are averaged.
Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Oxygen Saturation
The measured values during mechanical ventilation are averaged.
Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion
End-tidal carbon dioxide
The measured values during mechanical ventilation are averaged.
Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Tidal volume
The measured values during mechanical ventilation are averaged.
Measured: intraoperative period
Oropharyngeal leak pressure
The measured values during mechanical ventilation are averaged.
Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Leak volume and leak fraction
The measured values during mechanical ventilation are averaged. Leak volume is defined as the difference between inspired and expired tidal volume. Leak fraction is defined as the ratio of leak volume/inspired tidal volume.
Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Presence of blood staining on SGA
When the SGA is removed after the surgery, check whether there is blood staining on the SGA.
Measured: Immediately after the end of anesthesia
The duration of stay in the recovery room after surgery
The time from admission to the recovery room to discharge
Measured: upto 1 hour after entering the recovery room
Presence of postoperative nausea and vomiting
Postoperative nausea and vomiting which occur during the time from the end of surgery until discharge from the recovery room.
Measured: upto 1 hour after entering the recovery room
Presence of respiratory depression
Respiratory depression which occurs during the time from the end of surgery until discharge from the recovery room.
Measured: upto 1 hour after entering the recovery room
Presence of sore throat
Sore throat which occurs during the time from the end of surgery until discharge from the recovery room.
Measured: upto 1 hour after entering the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion2 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric VolumeStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BON WOOK KOO, Seoul National University Bundang Hospital
- Investigators
- Bon Wook Koo, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861569
- Sponsor's protocol ID
- SNUBH-LMASONOPEEP
- Status last verified
- Apr 2024
- First submitted
- 15 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Positive End-expiratory Pressure on the Gastric Volume in Patients Undergoing General Anesthesia with Supraglottic Airway Device: a Prospective Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06861569
- Acronym / sponsor ID
- SNUBH-LMASONOPEEP
- Keywords
- Supraglottic Airway Device, Postive End Expiratory Pressure, Gastric Sonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 2 Feb 2026 (estimated)
- First posted
- 6 Mar 2025 (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.
The main purpose of this study is to quantitatively evaluate the effect of applying PEEP during the use of SGA on gastric volume, aiming to provide objective evidence regarding the potential side effects, such as gastric volume increase. It is expected that this will contribute to improving the quality of patient management through the safe clinical use of SGA and PEEP.
Detailed description
General anesthesia has positive effects in relieving pain and unpleasant memories during surgery by blocking the patient's voluntary movements and reflexes to stimuli. However, it can lead to side effects such as severe impairment or absence of spontaneous breathing, necessitating artificial respiration. Among the conventional airway management methods for artificial respiration, the supraglottic airway device (SGA) has the advantage of reducing hemodynamic changes, intracranial pressure, and intraocular pressure caused by airway stimulation, as it does not pass through the airway, and it reduces airway-related complications. However, a disadvantage is its inability to adequately seal the airway, making it difficult to use in cases where there is a high risk of aspiration or when high airway pressures are required.
Positive End Expiratory Pressure (PEEP) has the advantage of preventing atelectasis, improving oxygen exchange capacity, and preventing pulmonary complications by maintaining lung expansion. However, applying PEEP increases airway pressure, and if the SGA does not adequately seal the airway, there is a possibility of air entering the stomach. If air enters the stomach and increases gastric volume, the risk of postoperative vomiting and aspiration pneumonia increases due to increased gastric pressure. Also, increased intra-abdominal pressure and diaphragmatic elevation can lead to respiratory distress due to decreased lung volume during postoperative recovery.
While there are studies suggesting that PEEP can be safely used with SGA, there is a need for verification as there are no studies objectively measuring changes in gastric volume using methods such as ultrasound when using PEEP with SGA. The main purpose of this study is to quantitatively evaluate the effect of applying PEEP during the use of SGA on gastric volume, aiming to provide objective evidence regarding the potential side effects, such as gastric volume increase. It is expected that this will contribute to improving the quality of patient management through the safe clinical use of SGA and PEEP.
Before entering the operating room, patients will be placed in a sitting and right lateral decubitus (RLD) position to measure the cross sectional area(CSA) of the stomach antrum using ultrasound. One investigator will scan the sagittal plane in the upper abdominal region using a low-frequency ultrasound probe (2-5 MHz) and measure the major diameter (D1) and transverse diameter (D2) of the observed antrum. CSA can be calculated from the measured values as in formula (a) below. The investigator will scan three times for each posture, and calculate the average.
CSA = D1 x D2 x 1/4 ------- (a) Using CSA, gastric volume (GV) is estimated using formula (b) below. GV (ml) = 27.0 + 14.6 × CSA - 1.28×age ------- (b) Midazolam premedication is not administered before surgery. When patients enter the operating room, standard monitoring devices (electrocardiogram, pulse oximetry, non-invasive blood pressure monitor, BIS or SedLine) are attached for vital sign monitoring, and target-controlled infusion of propofol is initiated at a target concentration of 4.0 µg/ml, and remifentanil at a target concentration of 3.0 ng/ml.
After confirming loss of consciousness and loss of spontaneous respiration, SGA is inserted, and the position of the SGA is evaluated and recorded using the fiberoptic scoring system.
During surgery, maintenance of anesthesia is managed with target-controlled infusion of propofol to keep BIS (Bispectral Index) between 40-60 or PSI (Patient State Index) between 25-49. For adequate analgesia during surgery, remifentanil is continuously infused using target-controlled infusion.
At 5 minutes (T0), 30 minutes (T1), and 60 minutes (T2) after SGA insertion, the following values related to mechanical ventilation are measured: FiO2 (Fraction of Inspired Oxygen), PIP (Peak Inspiratory Pressure), RR (Respiratory Rate), lung compliance, SpO2 (Oxygen Saturation), EtCO2 (End-tidal Carbon Dioxide), TV (Tidal Volume), OLP (Oropharyngeal Leak Pressure), leak volume, and leak fraction.
Immediately after surgery, CSAright-lat and GV are measured as described in above. After confirming that respiration and consciousness levels have returned to clinically normal conditions post-surgery, the patient is discharged to the recovery room, and assessments are made for nausea or vomiting, respiratory depression, sore throat, and blood staining.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZEEP | No intervention | –Patients undergoing general anesthesia using supraglottic airway device without PEEP. |
| PEEP | Experimental | Procedure: Positive end expiratory pressurePatients undergoing general anesthesia using supraglottic airway device with PEEP of 5cmH2O. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 19 and above.
- Patients scheduled for general anesthesia for elective surgery.
- American society of anesthesiologists physical status classification 1 or 2
Key exclusion criteria (10 listed)
- Individuals who have not provided prior consent for participation in the study
- Patients showing cognitive impairment to the extent that voluntary consent is difficult
- Obesity with a BMI of 30 kg/m² or higher
- Patients with anatomical abnormalities in the airway structure making supraglottic airway device application difficult
- Patients with respiratory diseases making PEEP application difficult (e.g., chronic obstructive pulmonary disease, asthma)
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 |
|---|---|---|
| Positive end expiratory pressurePositive end-expiratory pressure (PEEP) is a value that can be set up in patients receiving invasive or non-invasive mechanical ventilation. 5cmH2O PEEP will be applied to the PEEP group participants. | Procedure or surgery | PEEP |
Primary outcome
Gastric volume difference before and after surgery
Time frame: Baseline and end of surgery 0 minute
Before and after the surgery, the patient is positioned in a sitting position and then in the right lateral decubitus (RLD) position. Ultrasound is used to measure the cross-sectional area (CSA) of the gastric antrum and then it is substituted into the following equation to estimate gastric volume. GV (ml) = 27.0 + 14.6 × CSAright-lat - 1.28×age The scanning is performed three times for each position to obtain the average value.
14 secondary outcomes
Fraction of Inspired Oxygen
Time frame: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Peak Inspiratory pressure
Time frame: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Respiratory rate
Time frame: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Lung compliance
Time frame: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Oxygen Saturation
Time frame: 5 minutes, 30 minutes, 60 minutes after SGA insertion
End-tidal carbon dioxide
Time frame: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Tidal volume
Time frame: intraoperative period
Oropharyngeal leak pressure
Time frame: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Leak volume and leak fraction
Time frame: 5 minutes, 30 minutes, 60 minutes after SGA insertion
Presence of blood staining on SGA
Time frame: Immediately after the end of anesthesia
The duration of stay in the recovery room after surgery
Time frame: upto 1 hour after entering the recovery room
Presence of postoperative nausea and vomiting
Time frame: upto 1 hour after entering the recovery room
Presence of respiratory depression
Time frame: upto 1 hour after entering the recovery room
Presence of sore throat
Time frame: upto 1 hour after entering the recovery room
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Yes
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Enrolling by invitation
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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.
Bon Wook Koo study chair
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Positive end expiratory pressure in people with Gastric Volume and Breast Cancer Female, run by Seoul National University Bundang Hospital.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bon Wook Koo (+82-31-787-7509, tendong2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric volume difference before and after surgery (time frame: Baseline and end of surgery 0 minute). 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 6 Mar 2025.