[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555376":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":53,"interventions":66,"overallOfficials":75,"centralContacts":80,"locations":88,"responsibleParty":107,"collaborators":41,"id":110,"slug":41,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":41,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":41,"enrollmentInfo":118,"targetDuration":41,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":91,"whyStopped":41,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"National Institute of Respiratory Diseases, Mexico","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Muscle mass changes","Changes of muscle mass in kilograms measured by impedance bioelectric","From randomization to 6 months",[14,17,20,23,26,29,32,35,38],{"measure":15,"description":16,"timeFrame":12},"Swallow recovery","Time to safe swallowing diagnosed by fibroendoscopy evaluation of swallowing (FEES) and measured in months",{"measure":18,"description":19,"timeFrame":12},"Duration of enteral nutrition indication","Time from discharge to feeding tube removal",{"measure":21,"description":22,"timeFrame":12},"Feeding tube complications","Number of feeding tube infections, dysfunctions and oclusions during study period",{"measure":24,"description":25,"timeFrame":12},"Muscle functionality changes","Changes in functionality measured by medical research council scale in a scale of 0-60 points",{"measure":27,"description":28,"timeFrame":12},"Handgrip strenght changes","Changes in functionality assessed by handgrip strenght in kilogramos using a digital dynamometer",{"measure":30,"description":31,"timeFrame":12},"Frailty complications","Number of falls and fractures during study period",{"measure":33,"description":34,"timeFrame":12},"Hospital readmissions associated to dysphagia complications","Number of hospital readmissions assocciated to feeding tube infections, dysfunctions and oclusions during study period",{"measure":36,"description":37,"timeFrame":12},"6-month mortality","All-cause mortality during study period",{"measure":39,"description":40,"timeFrame":12},"Aspiration pneumonia incidence","Number of hospital readmissions due to aspiration pneumonia",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"RANDOMIZED","PARALLEL","Randomized Clinical Trial","TREATMENT",{"masking":48,"maskingDescription":49,"whoMasked":50},"DOUBLE","Amounts of protein was not revealed for participants",[51,52],"PARTICIPANT","OUTCOMES_ASSESSOR",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"High protein group","EXPERIMENTAL","100% of the energy requirements measured by indirect calorimetry (IC) or estimated, and a protein intake of 2.0 g\u002Fkg, will be prescribed",[59],"Other: High protein dose",{"label":61,"type":62,"description":63,"interventionNames":64},"Usual protein group","OTHER","100% of the energy requirements measured by IC or estimated, and a protein intake of 1.5 g\u002Fkg, will be prescribed.",[65],"Other: Usual protein dose",[67,71],{"type":62,"name":68,"description":69,"armGroupLabels":70,"otherNames":41},"High protein dose","High dose of protein (2.0 g\u002Fkg) will prescribed for home enteral nutrition",[55],{"type":62,"name":72,"description":73,"armGroupLabels":74,"otherNames":41},"Usual protein dose","Usual dose of protein (1.5 g\u002Fkg) will prescribed for home enteral nutrition",[61],[76],{"name":77,"affiliation":78,"role":79},"Ivan A Osuna-Padilla, PhD","Instituto Nacional de Enfermedades Respiratorias","PRINCIPAL_INVESTIGATOR",[81,85],{"name":77,"role":82,"phone":83,"phoneExt":41,"email":84},"CONTACT","+5216671035806","ivan.osuna@iner.gob.mx",{"name":86,"role":82,"phone":41,"phoneExt":41,"email":87},"Alan Garcia-Grimaldo, MSc","agarciag1716@gmail.com",[89],{"facility":90,"status":91,"city":92,"state":41,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"National Institute of Respiratory Diseases","RECRUITING","Mexico City","14080","Mexico","MX",{"type":97,"coordinates":98},"Point",[99,100],-99.12766,19.42847,{"lat":100,"lon":99},[103],{"name":104,"role":82,"phone":105,"phoneExt":41,"email":106},"Ana L Gomez-Rodriguez, MSc","+52 1 55 2573 2734","grolucia@yahoo.es",{"type":79,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Ivan Armando Osuna Padilla","Clinical Nutrition Manager","100555376",false,"NCT06511284","Nutritional Therapy in Patients With Post-extubation Dysphagia","Swallowing and Nutritional Therapy and Its Impact on Body Composition and Clinical Outcomes in Patients With Post-extubation Dysphagia","Inclusion Criteria:\n\n* Patients who required invasive mechanical ventilation during their hospital stay with a diagnosis of post-extubation dysphagia diagnosed by fibroendoscopy evaluation of swallowing (FEES).\n* Patients who discharged with a feeding tube.\n* Patients with signed informed consent.\n\nExclusion Criteria:\n\n* Patients with pre-existing dysphagia, or with neurological conditions that can cause dysphagia (e.g. multiple sclerosis, Parkinson's disease, Alzheimer's, myasthenia gravis).\n* Patients with chronic kidney disease, defined as a glomerular filtration rate \\\u003C60 ml\u002Fmin.\n* Patients discharged with a terminal condition and\u002For life expectancy of less than 3 months.\n* Diagnosis of HIV, upon receiving clinical follow-up by the team of specialists.","ALL","18 Years",{"count":119,"type":120},128,"ESTIMATED","INTERVENTIONAL",[123],"NA","The aim of this study is to evaluate the impact of the prescription of two doses of protein on the amount in kilograms of muscle mass and on the clinical evolution (time until safe swallowing, time until removal of the feeding stoma, number of hospital readmissions, feeding stoma infections, incidence of pneumonia, functionality, number of falls, fractures and mortality) at 6 months after hospital discharge in patients with enteral nutrition due to post-extubation dysphagia.",[126],"Dysphagia",[128,129,130,131,132],"enteral nutrition","nutritional assessment","nutritional therapy","Deglutition Disorders","rehabilitation","2024-07-15",{"date":135,"type":136},"2024-07-19","ACTUAL",{"date":138,"type":136},"2024-07-01",{"date":140,"type":120},"2027-12-01",{"name":5,"class":6},1]