Clinical trial · Interventional
Effect of Positive End-expiratory Pressure on the Gastric Volume
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia Complication | — | UNRESOLVED | — |
| Breast Cancer Female | — | UNRESOLVED | — |
| Gastric Volume | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Positive end expiratory pressure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- ZEEP
- description
- Patients undergoing general anesthesia using supraglottic airway device without PEEP.
- type
- EXPERIMENTAL
- label
- PEEP
- description
- Patients undergoing general anesthesia using supraglottic airway device with PEEP of 5cmH2O.
- interventionNames
- Procedure: Positive end expiratory pressure
Primary outcomes (1)
- measure
- Gastric volume difference before and after surgery
- timeFrame
- Baseline and end of surgery 0 minute
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients aged 19 and above. * Patients scheduled for general anesthesia for elective surgery. * American society of anesthesiologists physical status classification 1 or 2 Exclusion Criteria: * 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) * Patients with a history of gastrointestinal surgery * Pregnant women * Patients undergoing concurrent surgeries or collaborative procedures * Patients transferred from the intensive care unit
References
Publications (0)
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