A Prospective Observational Study Exploring the Prevalence and Measurement of Delayed Gastric Emptying in Critically Ill Adults Receiving Extracorporeal Membrane Oxygenation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Prevalence of delayed gastric emptying (number of participants experiencing delayed gastric emptying) using stomach ultrasound in participants receiving ECMO compared to those receiving mechanical ventilation but not receiving ECMO (STAGE A).
研究概览
简要总结
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The goal of this observational study is to learn whether the stomach takes longer to empty in patients on the intensive care unit who are receiving ECMO (a machine that temporarily takes over the role of the lungs and heart) compared to patients receiving support through a breathing machine (mechanical ventilation) only. It will also find the best way to measure stomach emptying at the bedside.
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The main questions it aims to answer are:
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What is the prevalence of slow stomach emptying and other stomach or bowel problems in patients receiving ECMO, compared to patients receiving mechanical ventilation but not receiving ECMO? (Stage A)
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What is the best bedside method to measure stomach emptying in patients receiving ECMO? (Stage B)
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Stage A of the study will involve measuring stomach emptying in study participants within four days of ICU admission, using two bedside methods:
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'Residual volumes' (removing liquid nutrition left in the stomach with a syringe, after this has been given through the participant's usual feeding tube)
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A stomach ultrasound scan The researchers will check for differences between patients receiving ECMO versus no ECMO, and how this relates to the nutrition patients receive and how well or unwell they become in ICU.
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In a smaller subgroup of patients receiving ECMO and participating in Stage B of the study, the researchers will also use scintigraphy. This is a standard research scan that tracks how the stomach empties by mixing a small, safe amount of radioactivity in the participant's usual liquid nutrition. The researchers will compare stomach emptying results from 'residual volumes' and stomach ultrasound with scintigraphy.
详细描述
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When patients are very unwell and admitted to the intensive care unit (ICU), they may need support for their breathing through a breathing machine (known as mechanical ventilation). Patients with severe heart or lung illness may also require life support using 'extracorporeal membrane oxygenation' (ECMO), a machine that takes over the role of the lungs and heart to keep them alive.
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These patients are primarily given nutrition in the liquid form, through a tube placed into their stomach via the nose or mouth ('gastric tube'). While gastric tube feeding is commonly used for patients requiring mechanical ventilation and ECMO, current research shows that these patients often do not receive enough nutrition through their gastric tubes.
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Slow stomach emptying (often referred to as 'delayed gastric emptying') and other stomach or bowel problems ('gastrointestinal' complications) are thought to be common reasons for not receiving enough nutrition in patients receiving ECMO. Several factors may put these patients at higher risk of delayed gastric emptying, including their high level of illness, complex sedation, unstable blood pressure, and poor blood flow to the gut. Despite this, there is limited research on delayed gastric emptying in patients receiving ECMO.
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Not receiving enough nutrition has been associated with longer hospital stays and higher risk of death in patients receiving ECMO, and poorer physical recovery from ICU. Health professionals need to know if the stomach is emptying adequately to ensure that patients receive the nutrition they need.
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A common way to measure how much liquid nutrition is in a patients' stomach is by removing liquid nutrition left in the stomach with a syringe through the gastric tube ('residual volumes'). While this is a quick and inexpensive method that can be used on the bedside, it has been shown to be imprecise in identifying delayed gastric emptying.
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Another method is stomach ultrasound, a painless scan which is commonly available and has shown promising results in healthy individuals and general ICU patients. However, this has not yet been tested in patients receiving ECMO.
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The standard research method for measuring how fast or slow the stomach empties is called 'scintigraphy'. Scintigraphy uses a small, safe amount of radioactivity mixed in the patient's liquid nutrition and a special camera to scan the stomach. However, this is more expensive, labour-intensive and requires portable equipment not available in most hospitals. Therefore, it is only used for research purposes in ICU.
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Without a suitable bedside method to measure stomach emptying, there is a risk that delayed gastric emptying may not be properly managed in clinical practice. This may lead to delays in treatment, such as giving medications or changing feeding strategies, or unnecessary interruptions of gastric tube feeding resulting in poor nutritional intake.
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This study has two stages:
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Stage A aims to observe whether the stomach takes longer to empty in patients receiving ECMO compared to patients receiving mechanical ventilation but not receiving ECMO, and whether this relates to the nutrition patients receive and how well or unwell they become in ICU.
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Stage B aims to identify the most appropriate method ('residual volumes' or stomach ultrasound) for measuring stomach emptying in ICU for this patient population.
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Stage A will aim to recruit 72 participants in total (36 receiving ECMO; 36 not receiving ECMO). Stomach emptying will be measured within four days of ICU admission using 'residual volumes' and stomach ultrasound, and differences between patients receiving ECMO versus no ECMO will be assessed. The study will also check whether delayed gastric emptying and any other gastrointestinal complications experienced by patients relate to how much nutrition patients receive during the first 14 days of their ICU stay, how well-nourished they are on ICU admission and discharge (nutritional status), and how well or unwell they become while in ICU (clinical outcomes).
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In stage B, scintigraphy will also be undertaken in a subgroup of 27 patients receiving ECMO from stage A to measure the rate of stomach emptying (how fast or slow the stomach empties) and stomach retention (the amount of liquid nutrition remaining in the stomach), and results from 'residual volumes' and stomach ultrasound will be compared with this.
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The investigators believe that findings from this study may help to better measure stomach emptying in clinical practice, inform timely management of delayed gastric emptying and in turn improve the nutrition patients receive and their clinical recovery.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA (non-ECMO group):
- •Within 72 hours of Guy's & St Thomas' ICU admission
- •Mechanically ventilated adults (≥18 years)
- •Receiving enteral nutrition (liquid nutrition) via a gastric (nasogastric or orogastric) feeding tube
- •Informed consent / advice for participation by consultee
- •Availability of study investigator or other trained healthcare professional on site to complete gastric emptying (stomach emptying) measurements
- •INCLUSION CRITERIA (ECMO group):
- •Within 72 hours of Guy's & St Thomas' ICU admission
- •Mechanically ventilated adults (≥18 years)
- •Receiving enteral nutrition (liquid nutrition) via a gastric (nasogastric or orogastric) feeding tube
- •Informed consent / advice for participation by consultee
- •Availability of study investigator or other trained healthcare professional on site to complete gastric emptying (stomach emptying) measurements
- •Receiving either veno-venous or veno-arterial ECMO
排除标准
- •Pregnancy
- •History of gastroparesis (long-term slow stomach emptying)
- •Current acute or long-term gastrointestinal pathology (stomach or bowel problem) that may influence gastric emptying (e.g. inflammatory bowel disease, coeliac disease, pancreatic exocrine insufficiency)
- •Current contraindication to enteral nutrition (liquid nutrition) (e.g. clinical or radiological evidence of bowel obstruction, bowel ischaemia, ileus, upper gastrointestinal bleeding)
- •Enteral nutrition (liquid nutrition) through a gastrostomy, jejunostomy or nasojejunal feeding tube
- •Current or previous oesophageal, stomach or major small bowel surgery
- •Known anatomical abnormality of the stomach (e.g. hiatus hernia)
- •Pericardial / abdominal drains or surgical wounds obstructing site of ultrasound scanning
- •Nuclear medicine therapeutic administration, or diagnostic scintigraphy investigation in the previous 72 hours
- •Unlikely to survive or withdrawal of life-sustaining treatment expected in the next 48 hours
研究组 & 干预措施
Non-ECMO group
Participants who are in ICU and receiving mechanical ventilation, but not receiving ECMO.
干预措施: Gastric (stomach) ultrasound measurement (Other)
Non-ECMO group
Participants who are in ICU and receiving mechanical ventilation, but not receiving ECMO.
干预措施: 'Residual volume' measurement (Other)
ECMO group
Participants who are in ICU and receiving both mechanical ventilation and ECMO.
干预措施: Gastric (stomach) ultrasound measurement (Other)
ECMO group
Participants who are in ICU and receiving both mechanical ventilation and ECMO.
干预措施: 'Residual volume' measurement (Other)
ECMO group
Participants who are in ICU and receiving both mechanical ventilation and ECMO.
干预措施: Scintigraphy (standard research method) (Other)
结局指标
主要结局
Prevalence of delayed gastric emptying (number of participants experiencing delayed gastric emptying) using stomach ultrasound in participants receiving ECMO compared to those receiving mechanical ventilation but not receiving ECMO (STAGE A).
时间窗: Assessment of delayed gastric emptying prevalence using ultrasound will be undertaken once for each participant, and this will be done within the first 4 days of admission to the participating ICU.
The prevalence of delayed gastric emptying will be determined using stomach ultrasound ('antral cross-sectional area') in all 72 participants of Stage A (including ECMO and non-ECMO groups). The assessment of delayed gastric emptying prevalence will involve five stomach ultrasound measurements undertaken at pre-defined timepoints over a 4-hour duration. This will include calculation of percentage gastric retention (% of liquid nutrition volume remaining in stomach relative to that originally administered), which will be based upon measurements of 'antral cross-sectional area' (cm2) and subsequent calculation of stomach volume (millilitres, mL) (see interventions section). The definition of delayed gastric emptying prevalence using ultrasound will be determined based upon the optimum association with gastric emptying measured via scintigraphy, as identified in Stage B.
Prevalence of delayed gastric emptying (number of participants experiencing delayed gastric emptying) using 'residual volumes' in participants receiving ECMO compared to those receiving mechanical ventilation but not receiving ECMO (STAGE A).
时间窗: Assessment of delayed gastric emptying prevalence using 'residual volumes' will be undertaken during the 24 hours preceding stomach ultrasound assessment (within the first 3 days admission to the ICU), based on 4-hourly 'residual volume' measurements.
The prevalence of delayed gastric emptying will be determined for all 72 participants of Stage A (including ECMO and non-ECMO groups) using 'residual volumes' measured in millilitres (mL) (see interventions section). Delayed gastric emptying will be defined as any 'residual volume' measurement of more than 400 mL (current local institutional protocol threshold).
Association of stomach ultrasound ('antral cross-sectional area') and 'residual volumes' for measuring stomach emptying compared with the standard research method of scintigraphy in participants receiving ECMO (STAGE B).
时间窗: Assessment of stomach emptying using scintigraphy will be undertaken once for each participant, and this will be done within the first 4 days of admission to the participating ICU.
Stomach emptying will be measured using scintigraphy in a subgroup of 27 participants receiving ECMO from Stage A. This will be determined based upon a combination of percentage (%) stomach retention calculated at pre-defined timepoints over a 4-hour duration (see interventions section), as well as stomach emptying rate (i.e. time \[minutes\] taken for half of the infused liquid nutrition to empty). These parameters will be compared with the those from stomach ultrasound and 'residual volume' measurements to determine the bedside clinical method with the optimum association.
次要结局
- Prevalence of other gastrointestinal complications (number of participants experiencing other gastrointestinal complications)(Daily, for the first 7 days of admission to the participating ICU (or until ECMO is discontinued for participants in the ECMO group / initiated for participants in the non-ECMO group, whichever occurs first).)
- Nutritional status(Baseline (i.e. once within the first 72 hours of admission to the participating ICU), and ICU discharge (i.e once within +- 72 hours of discharge from the participating ICU).)
- Nutritional delivery (mean percentage of energy and protein targets achieved)(Daily during the first 14 days of admission to the participating ICU (or until discharge from ICU/transfer to another institution/death/feeding tube removal/intentional reduction in liquid nutrition to support oral food intake; whichever occurs first).)
- Nutritional adequacy(Daily during the first 14 days of admission to the participating ICU (or until discharge from ICU/transfer to another institution/death/feeding tube removal/intentional reduction in liquid nutrition to support oral food intake; whichever occurs first).)
- ICU mortality(From day of recruitment until day of discharge from the participating ICU or death (whichever occurs first), assessed up to 60 days.)
- Hospital mortality(From day of recruitment through study completion (i.e. until day of discharge from institution or death, whichever occurs first), assessed up to 60 days.)
- Duration of ICU stay(From day of admission to the participating ICU until day of discharge from the participating ICU or death (whichever occurs first), assessed up to 60 days.)
- Duration of hospital stay(From day of admission to the participating institution through study completion (i.e. until day of discharge from the institution or death, whichever occurs first), assessed up to 60 days.)
- Duration of ECMO support(From day of ECMO initiation until day of ECMO decannulation (or day of discharge from the participating ICU or death, whichever occurs first), assessed up to 60 days.)
- Duration of mechanical ventilation(From day of mechanical ventilation initiation until day of mechanical ventilation cessation (or day of discharge from the participating ICU or death, whichever occurs first), assessed up to 60 days.)