Prevalence and Measurement of Delayed Gastric Emptying in Patients Receiving Extracorporeal Membrane Oxygenation

NCT07779174 | Not Yet Recruiting

• 2 other identifiers: 344452NIHR305256
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.
• The main questions it aims to answer are:
• 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)
• What is the best bedside method to measure stomach emptying in patients receiving ECMO? (Stage B)
• Stage A of the study will involve measuring stomach emptying in study participants within four days of ICU admission, using two bedside methods:
• 'Residual volumes' (removing liquid nutrition left in the stomach with a syringe, after this has been given through the participant's usual feeding tube)
• 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.
• 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.

Conditions

Gastric Emptying; Delayed Gastric Emptying; Critical Illness; ExtraCorporeal Membrane Oxygenation (ECMO)

Keywords

Gastric emptying; Critical Illness; Extracorporeal Membrane Oxygenation; Delayed gastric emptying; Nutrition

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

• 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).

  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).

  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.

• 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).

  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.

  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.

Secondary Outcomes (10)

• 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.

Study Arms (2)

Non-ECMO group

Participants who are in ICU and receiving mechanical ventilation, but not receiving ECMO.

Other: Gastric (stomach) ultrasound measurement; Other: 'Residual volume' measurement

ECMO group

Participants who are in ICU and receiving both mechanical ventilation and ECMO.

Other: Gastric (stomach) ultrasound measurement; Other: 'Residual volume' measurement; Other: Scintigraphy (standard research method)

Interventions

Gastric (stomach) ultrasound measurement OTHER

Gastric ultrasound will be performed within 4 days of admission to the participating ICU, for all 72 participants included in Stage A of the study. An ultrasound machine will be gently pressed against the participant's abdomen to measure how much liquid nutrition is left in their stomach over time. To do this, 100ml of liquid nutrition will be given through their gastric tube at the start of the scan. Five measurements will be taken in total, one at the start (baseline) and then one every hour for a total of four hours. A special measurement from the ultrasound scan ('antral cross-sectional area') will be used to calculate the amount of liquid in the stomach. In preparation for the scan, the participant's regular liquid nutrition will be paused for at least 4 hours.

ECMO group; Non-ECMO group

'Residual volume' measurement OTHER

'Residual volumes' are measured every four hours by nurses in ICU as part of routine care. A 'residual volume' measurement will be done for all 72 participants included in Stage A of the study immediately before the ultrasound scan. The measurements taken from each participant during the first 7 days of their ICU stay (including the 24 hours before gastric ultrasound measurements) will also be recorded from the electronic healthcare records.

ECMO group; Non-ECMO group

Scintigraphy (standard research method) OTHER

In addition to gastric ultrasound and residual volumes, scintigraphy will also be carried out for a subgroup of 27 patients receiving ECMO (i.e. those participating in stage B) to measure stomach emptying and stomach retention. The liquid nutrition given at the start of the scan will be mixed with a small and safe amount of radioactivity by a specialist Nuclear Medicine Physicist. A special camera (portable gamma camera) will then be placed over the participant's stomach, which will take images over four hours (one at baseline, then one every 15 minutes for the first hour, followed by every 30 minutes for the next three hours). Each scan will last up to 5 minutes. A Nuclear Medicine Physicist will then analyse the images. Patients who are suitable to have scintigraphy will be identified through discussion with their treating ICU consultant.

ECMO group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving mechanical ventilation (including those receiving ECMO) admitted to the Guy's \& St Thomas' Adult ICUs during the study period will be screened consecutively for eligibility against the inclusion / exclusion criteria. Eligibility screening will be done using the electronic healthcare record within 72 hours of admission to the participating ICU. All patients meeting all of the inclusion criteria and none of the exclusion criteria will be approached for consent and considered for recruitment if logistically feasible (i.e. if a trained staff member is available on site to undertake the gastric ultrasound/scintigraphy measurements). The total target sample size for this study is 72 patients (36 receiving ECMO; 36 not receiving ECMO).

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: collaborator
• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Gastroparesis; Critical Illness

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Professor Kevin Whelan, PhD

  King's College London

  STUDY DIRECTOR

Central Study Contacts

Terpsichori Karpasiti

CONTACT

+44 (0) 207 848 4552; terpsichori.karpasiti@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

GB (1)