protocolSection identificationModule nctId: NCT06382727, orgStudyIdInfo id: ER008, briefTitle: CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care, acronym: CONTINUE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Emma Ridley, class: OTHER, descriptionModule briefSummary: Critically ill patients admitted to the Intensive Care Unit (ICU) often need to be connected to a breathing machine (ventilator) and are unable to eat. During this time, liquid nutrition is delivered via a feeding tube to the stomach or bowel (termed enteral nutrition (EN)) to ensure nutrition needs are provided until such time that the patient can eat normally.The delivery of nutrition via EN is frequently interrupted due to procedures and changes in the gastrointestinal system that can cause digestion to be slow. One of the main contributors to EN interruptions is fasting prior to removal of the breathing tube (termed extubation).The practice of pausing EN prior to the removal of the breathing tube is historical and based on evidence for patients who are not within the ICU. There is currently no scientific consensus on whether pausing of EN is necessary, or for how long. Because of this, some clinicians choose to pause EN prior to removal of the breathing tube and some clinicians continue to provide EN.This study is a pilot randomised controlled trial of fasting patients for at least 4 hours prior to removal of the breathing tube compared with not pausing EN. The investigators hypothesise that this will reduce the number of hours of fasting in the 24 hours prior to extubation., conditionsModule conditions: Critical Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: CONTINUE is a multi-centre, open-label, prospective parallel, pilot randomised controlled trial being conducted in Australia., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: EN will be continued up to extubation (EN will not be withheld prior to extubation), outcomesModule primaryOutcomes measure: Fasting time (hours), secondaryOutcomes measure: Reintubation rate, secondaryOutcomes measure: Days alive and free of mechanical ventilation, secondaryOutcomes measure: Commencement of antibiotics, secondaryOutcomes measure: Ratio of oxygen saturation (SpO2)/ fraction of inspired oxygen (FiO2), secondaryOutcomes measure: ICU length of stay, secondaryOutcomes measure: In-hospital mortality, secondaryOutcomes measure: Nutrition delivery, secondaryOutcomes measure: Recruitment rate, secondaryOutcomes measure: Protocol compliance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gold Coast University Hospital, city: Southport, state: Queensland, zip: 4215, country: Australia, contacts name: James Mccullogh, Dr, role: CONTACT, geoPoint lat: -27.96724, lon: 153.39796, locations facility: St Vincent's Hospital Melbourne, city: Fitzroy, state: Victoria, zip: 3065, country: Australia, contacts name: Alastair Brown, Dr, role: CONTACT, geoPoint lat: -37.79839, lon: 144.97833, locations facility: The Alfred Hospital, city: Melbourne, state: Victoria, zip: 3004, country: Australia, contacts name: Emma Ridley, A/Prof, role: CONTACT, contacts name: Sean Keem, Dr, role: CONTACT, geoPoint lat: -37.814, lon: 144.96332, hasResults: False