Effect of a Liberal Fasting Regime (Sip-til-Send) on Preoperative Gastric Volume Measured Using Point of Care Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
Pulmonary aspiration of gastric contents during surgery is a rare but potentially catastrophic event. Current guidelines recommend that patients should fast for six hours for solid food and two hours for clear liquids. Despite this, many patients fast considerably longer than two hours for clear liquids, often as a result of logistical challenges.
In response to this, the Sip-to-Send concept was developed where patients are permitted to drink small amounts of clear liquid (170-200 ml per hour) until they are called to the operating department. The introduction of Sip-to-Send has been well received by patients and has been associated with increased patient satisfaction.
For planned general anaesthesia in the operating department, the incidence of pulmonary aspiration is estimated at approximately 1 per 4,500 anaesthetics. Because of this low incidence, it is in practice unrealistic to design studies using aspiration as the primary endpoint to demonstrate non-inferiority of new fasting regimens. For example, a study with a non-inferiority margin of 20%, power of 90% and a one-sided α of 0.025, based on an incidence of 1 per 4,500, would require approximately 2.6 million patients in each study arm.
Gastric ultrasound represents a rapid, non-invasive technique for estimating gastric volume by measuring the cross-sectional area of the antrum and subsequently calculating volume. Several studies have shown that cross-sectional area correlates reliably with gastric volume, with good inter- and intra-observer reliability.
Sip-to-Send has been established practice at the Day Surgery Department at Haukeland since October 2023. The purpose of this study is to investigate whether there is a clinically relevant change in gastric volume as a result of this liberal fasting regimen.
详细描述
Adult patients scheduled for general anaesthesia or deep sedation at the Day Surgery Department (DKS) will be recruited prospectively on the day of surgery by a member of the research team. Potential participants will be identified through review of the operating theatre scheduling system and, where necessary, review of the medical record for planned elective patients against the study inclusion and exclusion criteria. An exemption from the duty of confidentiality under Section 29 of the Norwegian Health Personnel Act will be sought for the necessary medical record reviews undertaken for recruitment purposes. Only necessary information will be reviewed, and informed consent will be obtained before any inclusion in the study.
The primary hypothesis of the study is that Sip-to-Send is not inferior to standard fasting, assessed as the within-individual change in gastric volume (primary analysis).
Following inclusion, a non-invasive gastric ultrasound examination will be performed using a curvilinear ultrasound probe on the abdomen. The examination will be performed both in the supine position and in the right lateral decubitus position. A video recording of each ultrasound examination will be made (120 seconds per examination), stored in coded and anonymised form, and later assessed by another member of the research group who is blinded to the patient's fasting status.
The development and validation of automated methods for measurement of antral cross-sectional area forms part of the secondary aims of this research project. Any future use of the video recordings beyond the purposes of this project will require separate regional ethics committee approval.
After the first ultrasound examination, the patient may drink up to 200 ml of clear liquid during the subsequent hour, in accordance with the Sip-to-Send protocol. The antral cross-sectional area will be calculated using the ultrasound machine's freehand tracing function when the stomach is at rest. The measurement will be performed by tracing the gastric serosa, defined as the outermost hyperechoic line. The total volume of liquid consumed will be documented.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to give written consent
- •Adult patient (> 18 years of age)
- •Planned general anaesthesia or deep sedation
- •Fasted for at least six hours for food and two hours for clear fluids upon arrival
- •Expected to wait at least one hour before surgery
排除标准
- •Unable to give written consent
- •Active gastrointestinal obstruction
- •Pregnancy
- •Ongoing opioid use
- •Previous stomach surgery - gastric banding / Roux-en-Y / sleeve gastrectomy
- •Use of GLP-1 agonist (Wegovy)
- •Type 1 or 2 diabetes