Effect of Positive End-expiratory Pressure on the Gastric Volume

NCT06861569 | Not Yet Recruiting

• 1 other identifier: SNUBH-LMASONOPEEP
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief 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. It is expected that this will contribute to improving the quality of patient management through the safe clinical use of SGA and PEEP.

Conditions

Gastric Volume; Breast Cancer Female; Anesthesia Complication

Keywords

Supraglottic Airway Device; Postive End Expiratory Pressure; Gastric Sonography

Outcome Measures

Primary Outcomes (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.

  Baseline and end of surgery 0 minute

Secondary Outcomes (14)

• Fraction of Inspired Oxygen

  5 minutes, 30 minutes, 60 minutes after SGA insertion

• Peak Inspiratory pressure

  5 minutes, 30 minutes, 60 minutes after SGA insertion

• Respiratory rate

  5 minutes, 30 minutes, 60 minutes after SGA insertion

• Lung compliance

  5 minutes, 30 minutes, 60 minutes after SGA insertion

• Oxygen Saturation

  5 minutes, 30 minutes, 60 minutes after SGA insertion

Study Arms (2)

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.

Procedure: Positive end expiratory pressure

Interventions

Positive end expiratory pressure PROCEDURE

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.

PEEP

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 19 and above.
• Patients scheduled for general anesthesia for elective surgery.
• American society of anesthesiologists physical status classification 1 or 2

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Bon Wook Koo

  Seoul National University Bundang Hospital

  STUDY CHAIR

Central Study Contacts

Bon Wook Koo

CONTACT

+82-31-787-7509; tendong2@gmail.com

Young Hyun Koo

CONTACT

+82-31-787-7499; yhkoo@snubh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: March 6, 2025
• Study Start: March 15, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 2, 2026
• Last Updated: March 6, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL