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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Young Hyun Koo contact

+82-31-787-7499

yhkoo@snubh.org

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 groups in NCT06861569
Study groupRoleWhat they receive
ZEEPNo interventionPatients undergoing general anesthesia using supraglottic airway device without PEEP.
PEEPExperimentalPatients 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.

  1. 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)
  1. Fraction of Inspired Oxygen

    The measured values during mechanical ventilation are averaged.

    Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion

  2. Peak Inspiratory pressure

    The measured values during mechanical ventilation are averaged.

    Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion

  3. Respiratory rate

    The measured values during mechanical ventilation are averaged.

    Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion

  4. Lung compliance

    The measured values during mechanical ventilation are averaged.

    Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion

  5. Oxygen Saturation

    The measured values during mechanical ventilation are averaged.

    Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion

  6. End-tidal carbon dioxide

    The measured values during mechanical ventilation are averaged.

    Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion

  7. Tidal volume

    The measured values during mechanical ventilation are averaged.

    Measured: intraoperative period

  8. Oropharyngeal leak pressure

    The measured values during mechanical ventilation are averaged.

    Measured: 5 minutes, 30 minutes, 60 minutes after SGA insertion

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  1. First posted6 Mar 2025
  2. Study start15 Mar 2025 (estimated)
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion2 Feb 2026 (estimated)

Resources

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)
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

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.

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