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

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)

Interventions

OTHER

Gastric (stomach) ultrasound measurement

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.

OTHER

'Residual volume' measurement

'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.

OTHER

Scintigraphy (standard research method)

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.

Sponsors & Collaborators

• King's College London

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  lead OTHER

Principal Investigators

• Professor Kevin Whelan, PhD · King's College London

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2028-05-31

Completion

2028-06-30

Countries

• United Kingdom

Study Locations