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临床试验/NCT06861569
NCT06861569尚未招募不适用

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

Seoul National University Bundang Hospital0 个研究点目标入组 128 人开始时间: 2025年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
128
主要终点
Gastric volume difference before and after surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Positive end expiratory pressure (Procedure)

结局指标

主要结局

Gastric volume difference before and after surgery

时间窗: 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.

次要结局

  • 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)
  • End-tidal carbon dioxide(5 minutes, 30 minutes, 60 minutes after SGA insertion)
  • Tidal volume(intraoperative period)
  • Oropharyngeal leak pressure(5 minutes, 30 minutes, 60 minutes after SGA insertion)
  • Leak volume and leak fraction(5 minutes, 30 minutes, 60 minutes after SGA insertion)
  • Presence of blood staining on SGA(Immediately after the end of anesthesia)
  • The duration of stay in the recovery room after surgery(upto 1 hour after entering the recovery room)
  • Presence of postoperative nausea and vomiting(upto 1 hour after entering the recovery room)
  • Presence of respiratory depression(upto 1 hour after entering the recovery room)
  • Presence of sore throat(upto 1 hour after entering the recovery room)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

BON WOOK KOO

Professor

Seoul National University Bundang Hospital

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