[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652915":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":77,"collaborators":79,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":10,"studyType":95,"phases":10,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":107,"whyStopped":10,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Guy's and St Thomas' NHS Foundation Trust","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-ECMO group",null,"Participants who are in ICU and receiving mechanical ventilation, but not receiving ECMO.",[13,14],"Other: Gastric (stomach) ultrasound measurement","Other: 'Residual volume' measurement",{"label":16,"type":10,"description":17,"interventionNames":18},"ECMO group","Participants who are in ICU and receiving both mechanical ventilation and ECMO.",[13,14,19],"Other: Scintigraphy (standard research method)",[21,25,29],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"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.\n\nTo 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.",[16,9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"'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.",[16,9],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"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.\n\nThe 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.",[16],[34],{"name":35,"affiliation":36,"role":37},"Professor Kevin Whelan, PhD","King's College London","STUDY_DIRECTOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},"Terpsichori Karpasiti","CONTACT","+44 (0) 207 848 4552","terpsichori.karpasiti@kcl.ac.uk",[45],{"facility":46,"status":10,"city":47,"state":10,"zip":10,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Guy's & St Thomas' NHS Foundation Trust","London","United Kingdom","UK",{"type":51,"coordinates":52},"Point",[53,54],-0.12574,51.50853,{"lat":54,"lon":53},[57,62,65,67,69,71,73,75],{"name":58,"role":41,"phone":59,"phoneExt":60,"email":61},"Rachel Fay","+44 (0) 207 188 7188","54426","gstt.RandD@nhs.net",{"name":63,"role":64,"phone":10,"phoneExt":10,"email":10},"Dr Brijesh Patel","PRINCIPAL_INVESTIGATOR",{"name":66,"role":64,"phone":10,"phoneExt":10,"email":10},"Dr Hatem Aboumarie",{"name":68,"role":64,"phone":10,"phoneExt":10,"email":10},"Dr Richard Paul",{"name":40,"role":70,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":72,"role":70,"phone":10,"phoneExt":10,"email":10},"Prof Louise Rose",{"name":74,"role":70,"phone":10,"phoneExt":10,"email":10},"Dr Danielle Bear",{"name":76,"role":70,"phone":10,"phoneExt":10,"email":10},"Ms Lucy Hossen",{"type":78,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[80],{"name":36,"class":6},"100652915","prevalence-and-measurement-of-delayed-gastric-emptying-in-patients-receiving-extracorporeal-membrane-oxygenation-100652915",false,"NCT07779174","Prevalence and Measurement of Delayed Gastric Emptying in Patients Receiving Extracorporeal Membrane Oxygenation","A Prospective Observational Study Exploring the Prevalence and Measurement of Delayed Gastric Emptying in Critically Ill Adults Receiving Extracorporeal Membrane Oxygenation","PROPEL-ECMO","* INCLUSION CRITERIA (non-ECMO group):\n\n  * Within 72 hours of Guy's \\& St Thomas' ICU admission\n  * Mechanically ventilated adults (≥18 years)\n  * Receiving enteral nutrition (liquid nutrition) via a gastric (nasogastric or orogastric) feeding tube\n  * Informed consent \u002F advice for participation by consultee\n  * Availability of study investigator or other trained healthcare professional on site to complete gastric emptying (stomach emptying) measurements\n* INCLUSION CRITERIA (ECMO group):\n\n  * Within 72 hours of Guy's \\& St Thomas' ICU admission\n  * Mechanically ventilated adults (≥18 years)\n  * Receiving enteral nutrition (liquid nutrition) via a gastric (nasogastric or orogastric) feeding tube\n  * Informed consent \u002F advice for participation by consultee\n  * Availability of study investigator or other trained healthcare professional on site to complete gastric emptying (stomach emptying) measurements\n  * Receiving either veno-venous or veno-arterial ECMO\n* EXCLUSION CRITERIA:\n\n  * Pregnancy\n  * History of gastroparesis (long-term slow stomach emptying)\n  * 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)\n  * Current contraindication to enteral nutrition (liquid nutrition) (e.g. clinical or radiological evidence of bowel obstruction, bowel ischaemia, ileus, upper gastrointestinal bleeding)\n  * Enteral nutrition (liquid nutrition) through a gastrostomy, jejunostomy or nasojejunal feeding tube\n  * Current or previous oesophageal, stomach or major small bowel surgery\n  * Known anatomical abnormality of the stomach (e.g. hiatus hernia)\n  * Pericardial \u002F abdominal drains or surgical wounds obstructing site of ultrasound scanning\n  * Nuclear medicine therapeutic administration, or diagnostic scintigraphy investigation in the previous 72 hours\n  * Unlikely to survive or withdrawal of life-sustaining treatment expected in the next 48 hours","ALL","18 Years","80 Years",{"count":93,"type":94},72,"ESTIMATED","OBSERVATIONAL","* 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.\n* The main questions it aims to answer are:\n\n  * 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)\n  * What is the best bedside method to measure stomach emptying in patients receiving ECMO? (Stage B)\n* Stage A of the study will involve measuring stomach emptying in study participants within four days of ICU admission, using two bedside methods:\n\n  * 'Residual volumes' (removing liquid nutrition left in the stomach with a syringe, after this has been given through the participant's usual feeding tube)\n  * 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.\n* 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.",[98,99,100,101],"Gastric Emptying","Delayed Gastric Emptying","Critical Illness","ExtraCorporeal Membrane Oxygenation (ECMO)",[103,100,104,105,106],"Gastric emptying","Extracorporeal Membrane Oxygenation","Delayed gastric emptying","Nutrition","NOT_YET_RECRUITING","2026-08-19",{"date":110,"type":111},"2026-08-21","ACTUAL",{"date":113,"type":94},"2026-09",{"date":115,"type":94},"2028-06",{"name":5,"class":6},1]