[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555352":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":224,"collaborators":25,"id":226,"slug":227,"hasResults":228,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":228,"sex":234,"minAge":235,"maxAge":25,"enrollmentInfo":236,"targetDuration":25,"studyType":239,"phases":240,"briefSummary":242,"conditions":243,"keywords":249,"overallStatus":60,"whyStopped":25,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":265},{"fullName":5,"class":6},"University Hospital, Tours","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral intake continuation strategy","EXPERIMENTAL","The patient will be allowed to ingest liquids or solid foods orally, of any type, at an unrestricted frequency and quantity, according to their tolerance, with nurse assistance if necessary. Essential treatments will be administered orally when applicable. The patient will receive regular oral care. Both oral and intravenous intake will be quantified. The physician in charge must ensure that the patient receives a minimal caloric intake, either through intravenous glucose supplementation or parenteral nutrition, with the quantity left to the physician's discretion.",[13],"Procedure: Oral intake continuation strategy",{"label":15,"type":16,"description":17,"interventionNames":18},"Fasting strategy","ACTIVE_COMPARATOR","The patient will not be allowed to ingest any liquids or solid foods. The patient will receive regular oral care. Essential oral medications, if no parenteral alternative is available, may be administered under nurse supervision (maximum daily water intake: 100 mL). The physician in charge must ensure that the patient receives a minimal caloric intake through intravenous glucose supplementation or parenteral nutrition, with the quantity left to the physician's discretion.",[19],"Procedure: Fasting strategy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","The patient will be allowed to ingest liquids or solid foods orally, of any type, at an unrestricted frequency and quantity, according to their tolerance.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The patient will not be able to ingest liquids or solid food.",[15],[30],{"name":31,"affiliation":32,"role":33},"Piotr SZYCHOWIAK, MD","University Hospital, Orléans","STUDY_DIRECTOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","2.38.22.95.58","+33","piotr.szychowiak@gmail.com",[41,58,72,85,98,110,123,136,149,162,174,187,200,213],{"facility":42,"status":43,"city":44,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Intensive care, University Hospital, Blois","NOT_YET_RECRUITING","Blois","France","FR",{"type":48,"coordinates":49},"Point",[50,51],1.32912,47.59432,{"lat":51,"lon":50},[54,56],{"name":55,"role":36,"phone":25,"phoneExt":25,"email":25},"Julien GROUILLE, MD",{"name":55,"role":57,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":59,"status":60,"city":61,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Intensive care, Hospital, Bourges","RECRUITING","Bourges",{"type":48,"coordinates":63},[64,65],2.4,47.08333,{"lat":65,"lon":64},[68,70],{"name":69,"role":36,"phone":25,"phoneExt":25,"email":25},"Anna BOURREAU, MD",{"name":71,"role":57,"phone":25,"phoneExt":25,"email":25},"Anna BOURREAU",{"facility":73,"status":60,"city":74,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Intensive care, Hospital, Colombes","Colombes",{"type":48,"coordinates":76},[77,78],2.25404,48.91882,{"lat":78,"lon":77},[81,83],{"name":82,"role":36,"phone":25,"phoneExt":25,"email":25},"Damien ROUX, MCU-PH",{"name":84,"role":57,"phone":25,"phoneExt":25,"email":25},"Damien ROUX",{"facility":86,"status":60,"city":87,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Intensive care, Hospital, Dreux","Dreux",{"type":48,"coordinates":89},[90,91],1.36566,48.73649,{"lat":91,"lon":90},[94,96],{"name":95,"role":36,"phone":25,"phoneExt":25,"email":25},"Thomas JANSON, MD",{"name":97,"role":57,"phone":25,"phoneExt":25,"email":25},"Thomas JANSON",{"facility":99,"status":60,"city":100,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Intensive care, Hospital, La Roche sur Yon","La Roche-sur-Yon",{"type":48,"coordinates":102},[103,104],-1.42757,46.66974,{"lat":104,"lon":103},[107,109],{"name":108,"role":36,"phone":25,"phoneExt":25,"email":25},"Laureen GUILLEMIN, MD",{"name":108,"role":57,"phone":25,"phoneExt":25,"email":25},{"facility":111,"status":60,"city":112,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Intensive care, Hospital, Le MANS","Le Mans",{"type":48,"coordinates":114},[115,116],0.20251,48.0021,{"lat":116,"lon":115},[119,121],{"name":120,"role":36,"phone":25,"phoneExt":25,"email":25},"Mickael LANDAIS, MD",{"name":122,"role":57,"phone":25,"phoneExt":25,"email":25},"Mickael LANDAIS",{"facility":124,"status":60,"city":125,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Intensive care, Hospital, Lille","Lille",{"type":48,"coordinates":127},[128,129],3.05512,50.63391,{"lat":129,"lon":128},[132,134],{"name":133,"role":36,"phone":25,"phoneExt":25,"email":25},"Saadalla NSEIR, MD",{"name":135,"role":57,"phone":25,"phoneExt":25,"email":25},"Saadalla NSEIR",{"facility":137,"status":60,"city":138,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Intensive care, Hospital, Morlaix","Morlaix",{"type":48,"coordinates":140},[141,142],-3.82792,48.57784,{"lat":142,"lon":141},[145,147],{"name":146,"role":36,"phone":25,"phoneExt":25,"email":25},"Pierre-Yves EGRETEAU, MD",{"name":148,"role":57,"phone":25,"phoneExt":25,"email":25},"Pierre-Yves EGRETEAU",{"facility":150,"status":60,"city":151,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Intensive care, Hospital, Nantes","Nantes",{"type":48,"coordinates":153},[154,155],-1.55336,47.21725,{"lat":155,"lon":154},[158,160],{"name":159,"role":36,"phone":25,"phoneExt":25,"email":25},"Jean REIGNIER, MCU-PH",{"name":161,"role":57,"phone":25,"phoneExt":25,"email":25},"Jean REIGNIER",{"facility":163,"status":60,"city":164,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Intensive care, University Hospital, Orléans","Orléans",{"type":48,"coordinates":166},[167,168],1.90407,47.90248,{"lat":168,"lon":167},[171,172],{"name":31,"role":36,"phone":25,"phoneExt":25,"email":25},{"name":173,"role":57,"phone":25,"phoneExt":25,"email":25},"Piotr SZYCHOWIAK",{"facility":175,"status":60,"city":176,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Intensive care, Hospital, poitiers","Poitiers",{"type":48,"coordinates":178},[179,180],0.34348,46.58261,{"lat":180,"lon":179},[183,185],{"name":184,"role":36,"phone":25,"phoneExt":25,"email":25},"Sylvain LE PAPE, MD",{"name":186,"role":57,"phone":25,"phoneExt":25,"email":25},"Sylvain LE PAPE",{"facility":188,"status":60,"city":189,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Intensive care, Hospital, Saint Brieuc","Saint-Brieuc",{"type":48,"coordinates":191},[192,193],-2.76838,48.51513,{"lat":193,"lon":192},[196,198],{"name":197,"role":36,"phone":25,"phoneExt":25,"email":25},"Nicolas MASSART, MD",{"name":199,"role":57,"phone":25,"phoneExt":25,"email":25},"Nicolas MASSART",{"facility":201,"status":60,"city":202,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Intensive care, Hospital, Saint-Nazaire","Saint-Nazaire",{"type":48,"coordinates":204},[205,206],-2.2179,47.27506,{"lat":206,"lon":205},[209,211],{"name":210,"role":36,"phone":25,"phoneExt":25,"email":25},"Patricia COUROUBLE, MD",{"name":212,"role":57,"phone":25,"phoneExt":25,"email":25},"Patricia COUROUBLE",{"facility":214,"status":60,"city":215,"state":25,"zip":25,"country":45,"countryCode":46,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Intensive care, University Hospital, Tours","Tours",{"type":48,"coordinates":217},[218,219],0.70398,47.39484,{"lat":219,"lon":218},[222],{"name":223,"role":57,"phone":25,"phoneExt":25,"email":25},"Stephan EHRMANN",{"type":225,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100555352","non-inferiority-of-continuing-oral-intake-versus-fasting-in-patients-with-acute-respiratory-failure-100555352",false,"NCT06510972","Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure","Continuation of Oral Intake Compared With Fasting in Patients With Acute Respiratory Failure Before Intubation : a Non-inferiority Randomized Clinical Trial","JEUN-TUBE","Inclusion Criteria:\n\n* Male or female ≥ 18 years old\n* Participant affiliated to a social security scheme\n* Express oral consent of the participant, or failing that of the trusted support person, or failing that of the next of kin\n* Patient hospitalised in an intensive care unit or in a continuous surveillance unit or in an intensive care unit for less than 24 hours.\n* Criteria for acute hypoxaemic respiratory failure defined as.\n\n  * Respiratory rate \\> 25 cpm or indifferent if SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) infection occurred ≥ 1 time since admission.\n  * PaO2\u002FFiO2 \\\u003C 200 mmHg or equivalent SpO2 (oxygen saturation)\u002FFiO2 (fraction of inspired oxygen) i.e. \\\u003C 235 (measured under at least 10 L\u002Fmin high concentration mask)\n\nExclusion Criteria:\n\n* Patient with criteria for immediate intubation:\n\n  * Persistent or worsening respiratory failure (respiratory rate \\> 40\u002Fmin, respiratory failure on physical examination, respiratory acidosis with pH (hydrogen potential ) \\\u003C 7.25, copious tracheal secretions, hypoxia with SpO2 \\\u003C 90% despite FiO2 \\> 80% for more than 5 minutes without technical dysfunction).\n  * Major haemodynamic failure (need for increasing vasopressor support with instability and hypoperfusion).\n  * Neurological failure (Glasgow score \\\u003C 8).\n  * Cardiac or respiratory arrest\n* Chronic lung disease: chronic obstructive pulmonary disease (GOLD grade 3 or 4: Global Initiative for Chronic Obstructive Lung Disease) or other chronic lung disease requiring long-term oxygen or ventilation (this does not include a patient undergoing continuous positive nocturnal pressure for sleep apnoea syndrome).\n* Contraindications to oral nutrition: known previous swallowing problems or inability to swallow, digestive sutures, admission for inhalation pneumonia, exclusive parenteral nutrition, etc.\n* Patients with a nasogastric or orogastric tube, a jejunostomy or a feeding ileostomy\n* Patient already on invasive mechanical ventilation on admission\n* Limitation of therapies including a decision not to intubate\n* Incapacitated adult (guardianship or curators)\n* Pregnant, parturient or breast-feeding women\n* Tracheostomised patient\n* Patient already included for the first time in this study","ALL","18 Years",{"count":237,"type":238},754,"ESTIMATED","INTERVENTIONAL",[241],"NA","Fasting in intensive care is mainly studied in mechanically ventilated patients or those in the weaning phase. Recent research challenge the common assumption of fasting and suggests that continuing enteral nutrition before extubation may be beneficial. Fasting is also practiced before procedures (e.g., tracheostomy, endoscopy) or surgeries, based on anesthetic guidelines. Yet, no data address fasting in non-intubated ICU patients with acute respiratory failure, despite frequent caloric deficits and inadequate nutritional intake.\n\nAspiration risk often justifies fasting, but studies indicate that swallowing reflexes remain intact in patients receiving high-flow nasal oxygen or non-invasive ventilation. Moreover, although intubation carries a 2-5.9% aspiration risk, rapid sequence induction mitigates this, questioning the necessity of preventive fasting. Despite its prevalence, this practice lacks scientific validation and guideline support.\n\nPatient discomfort is also significant. Hunger and thirst are major sources of distress, and evidence from anesthesiology suggests that allowing fluid intake pre-anesthesia reduces discomfort. Extrapolating these findings to ICU patients could improve well-being.\n\nIn conclusion, fasting in ICU patients may contribute to discomfort, dehydration, and malnutrition, while its protective benefits remain uncertain. We hypothesize that maintaining oral intake does not increase the risk of intubation or aspiration-related complications.",[244,245,246,247,248],"Respiratory Insufficiency","Fasting","Dysphagia","Swallowing Disorder","Aspiration",[250,251,252,253,254,255],"acute respiratory failure","fasting","oral intake","aspiration","intubation","high-flow nasal oxygen","2026-02-13",{"date":258,"type":259},"2026-02-18","ACTUAL",{"date":261,"type":259},"2025-02-05",{"date":263,"type":238},"2028-03",{"name":5,"class":6},14]