[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573804":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":301,"collaborators":304,"id":309,"slug":310,"hasResults":311,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":311,"sex":317,"minAge":318,"maxAge":23,"enrollmentInfo":319,"targetDuration":23,"studyType":322,"phases":323,"briefSummary":325,"conditions":326,"keywords":330,"overallStatus":40,"whyStopped":23,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":352},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fasting","ACTIVE_COMPARATOR","Patients randomized to the Fasting arm will have tube feeding stopped at least 8 hours before the scheduled surgery or procedure time.",[13],"Other: Fasting",{"label":15,"type":10,"description":16,"interventionNames":17},"Not Fasting","Patients randomized to the Not Fasting arm will have tube feeding continued until transfer to the operating room\u002Fprocedure area.",[18],"Other: Not fasting",[20,24],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"Process: Fasting pre-procedure\n\nTube feeding will be stopped at least 8 hours before the patient's scheduled surgery or procedure time.",[9],null,{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Not fasting","Process: Not fasting pre-procedure\n\nTube feeding will be continued until patient transfer to the operating room\u002Fprocedure area.",[15],[29],{"name":30,"affiliation":5,"role":31},"Alexander Nagrebetsky, MD, MSC","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":23,"email":36},"CONTACT","617-724-3292","anagrebetsky@mgh.harvard.edu",[38,57,71,86,101,116,127,142,155,164,178,193,207,218,232,246,261,272,287],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Stanford Medical Center","RECRUITING","Palo Alto","California","94305","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-122.14302,37.44188,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":23,"email":56},"Pedro Tanaka, MD, PhD, MACM","(650) 498-6000","ptanaka@stanford.edu",{"facility":58,"status":40,"city":59,"state":42,"zip":60,"country":44,"countryCode":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"UCSF Medical Center Parnassus","San Francisco","94143",{"type":47,"coordinates":62},[63,64],-122.41942,37.77493,{"lat":64,"lon":63},[67],{"name":68,"role":34,"phone":69,"phoneExt":23,"email":70},"Lee-lynn Chen, MD","(415) 567-6600","Lee-lynn.Chen@ucsf.edu",{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":44,"countryCode":45,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"University of Colorado Medical Center","NOT_YET_RECRUITING","Aurora","Colorado","80045",{"type":47,"coordinates":78},[79,80],-104.83192,39.72943,{"lat":80,"lon":79},[83],{"name":84,"role":34,"phone":85,"phoneExt":23,"email":23},"Ana Fernandez-Bustamante, MD, PhD, FASA","720-848-0000",{"facility":87,"status":73,"city":88,"state":89,"zip":90,"country":44,"countryCode":45,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"University of Miami Hospital","Miami","Florida","33136",{"type":47,"coordinates":92},[93,94],-80.19366,25.77427,{"lat":94,"lon":93},[97],{"name":98,"role":34,"phone":99,"phoneExt":23,"email":100},"Alexander Fort III, MD","305-243-4000","acfort@med.miami.edu",{"facility":102,"status":40,"city":103,"state":104,"zip":105,"country":44,"countryCode":45,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"McGaw Medical Center of Northwestern","Chicago","Illinois","60611",{"type":47,"coordinates":107},[108,109],-87.65005,41.85003,{"lat":109,"lon":108},[112],{"name":113,"role":34,"phone":114,"phoneExt":23,"email":115},"Ravindra Gupta, MD, FASA, FCCP","(312) 503-7975","Ravindra.Gupta@nm.org",{"facility":117,"status":40,"city":103,"state":104,"zip":118,"country":44,"countryCode":45,"cosmosGeoPoint":119,"geoPoint":121,"contacts":122},"Rush University Medical Center","60612",{"type":47,"coordinates":120},[108,109],{"lat":109,"lon":108},[123],{"name":124,"role":34,"phone":125,"phoneExt":23,"email":126},"Alisha Sachdev, MD","(888) 352-7874","Alisha_Sachdev@rush.edu",{"facility":128,"status":73,"city":129,"state":130,"zip":131,"country":44,"countryCode":45,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"University of Maryland Medical Center","Baltimore","Maryland","21201",{"type":47,"coordinates":133},[134,135],-76.61219,39.29038,{"lat":135,"lon":134},[138],{"name":139,"role":34,"phone":140,"phoneExt":23,"email":141},"Megan Anders, MD","(410) 328-8600","manders@som.umaryland.edu",{"facility":143,"status":40,"city":144,"state":145,"zip":146,"country":44,"countryCode":45,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Mass General Hospital","Boston","Massachusetts","02114",{"type":47,"coordinates":148},[149,150],-71.05977,42.35843,{"lat":150,"lon":149},[153],{"name":154,"role":34,"phone":23,"phoneExt":23,"email":23},"Alex Nagrebetsky",{"facility":156,"status":40,"city":144,"state":145,"zip":157,"country":44,"countryCode":45,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"Brigham & Women's Hospital","02115",{"type":47,"coordinates":159},[149,150],{"lat":150,"lon":149},[162],{"name":163,"role":34,"phone":23,"phoneExt":23,"email":23},"Gyorgy Frendl",{"facility":165,"status":40,"city":166,"state":145,"zip":167,"country":44,"countryCode":45,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"University of Massachusetts Memorial Medical Center","Worcester","01655",{"type":47,"coordinates":169},[170,171],-71.80229,42.26259,{"lat":171,"lon":170},[174],{"name":175,"role":34,"phone":176,"phoneExt":23,"email":177},"Guido Musch, MD, MBA","(508) 334-1000","Guido.Musch@umassmed.edu",{"facility":179,"status":40,"city":180,"state":181,"zip":182,"country":44,"countryCode":45,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"University of Minnesota Medical Center","Minneapolis","Minnesota","55455",{"type":47,"coordinates":184},[185,186],-93.26384,44.97997,{"lat":186,"lon":185},[189],{"name":190,"role":34,"phone":191,"phoneExt":23,"email":192},"Benjamin Keith, MD","855-324-7843","keith200@umn.edu",{"facility":194,"status":40,"city":195,"state":195,"zip":196,"country":44,"countryCode":45,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Columbia University Irvine Medical Center","New York","10032",{"type":47,"coordinates":198},[199,200],-74.00597,40.71427,{"lat":200,"lon":199},[203],{"name":204,"role":34,"phone":205,"phoneExt":23,"email":206},"Vivek Moitra, MD, FASA, FCCP","(212) 305-2500","vm2161@cumc.columbia.edu",{"facility":208,"status":40,"city":195,"state":195,"zip":209,"country":44,"countryCode":45,"cosmosGeoPoint":210,"geoPoint":212,"contacts":213},"Memorial Sloan Kettering Cancer Center","10065",{"type":47,"coordinates":211},[199,200],{"lat":200,"lon":199},[214],{"name":215,"role":34,"phone":216,"phoneExt":23,"email":217},"David Amar, MD","212-639-2000","amard@mskcc.org",{"facility":219,"status":73,"city":220,"state":195,"zip":221,"country":44,"countryCode":45,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"University of Rochester Medical Center","Rochester","14642",{"type":47,"coordinates":223},[224,225],-77.61556,43.15478,{"lat":225,"lon":224},[228],{"name":229,"role":34,"phone":230,"phoneExt":23,"email":231},"Jacob Nadler, MD, PhD, FASA","(585) 275-2100","Jacob_Nadler@URMC.Rochester.edu",{"facility":233,"status":40,"city":234,"state":195,"zip":235,"country":44,"countryCode":45,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Montefiore Medical Center","The Bronx","10467",{"type":47,"coordinates":237},[238,239],-73.86641,40.84985,{"lat":239,"lon":238},[242],{"name":243,"role":34,"phone":244,"phoneExt":23,"email":245},"Michael Kiyatkin, MD","718-920-4321","mkiyatkin@montefiore.org",{"facility":247,"status":40,"city":248,"state":249,"zip":250,"country":44,"countryCode":45,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Wake Forest University Health Sciences","Winston-Salem","North Carolina","27103",{"type":47,"coordinates":252},[253,254],-80.24422,36.09986,{"lat":254,"lon":253},[257],{"name":258,"role":34,"phone":259,"phoneExt":23,"email":260},"Ashish Khanna, MD, FCCP, FCCM","336-758-5000","akhanna@wakehealth.edu",{"facility":262,"status":263,"city":264,"state":265,"zip":266,"country":44,"countryCode":45,"cosmosGeoPoint":267,"geoPoint":271,"contacts":23},"Cleveland Clinic","ACTIVE_NOT_RECRUITING","Cleveland","Ohio","44195",{"type":47,"coordinates":268},[269,270],-81.69541,41.4995,{"lat":270,"lon":269},{"facility":273,"status":40,"city":274,"state":275,"zip":276,"country":44,"countryCode":45,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"University of Texas Medical Branch","Galveston","Texas","77555",{"type":47,"coordinates":278},[279,280],-94.7977,29.30135,{"lat":280,"lon":279},[283],{"name":284,"role":34,"phone":285,"phoneExt":23,"email":286},"Marcos Vidal Melo, MD, PhD","409-772-1011","mfvidalm@UTMB.EDU",{"facility":288,"status":73,"city":289,"state":275,"zip":290,"country":44,"countryCode":45,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"UT Health Houston","Houston","77030",{"type":47,"coordinates":292},[293,294],-95.36327,29.76328,{"lat":294,"lon":293},[297],{"name":298,"role":34,"phone":299,"phoneExt":23,"email":300},"Turan Mehmet, MD","713-486-1000","mehmet.a.turan@uth.tmc.edu",{"type":31,"investigatorFullName":302,"investigatorTitle":303,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Alexander Nagrebetsky, MD MSc","Anesthesia Attending",[305,307],{"name":306,"class":6},"Patient-Centered Outcomes Research Institute",{"name":308,"class":6},"Columbia University","100573804","preoperative-fasting-vs-not-fasting-in-critically-ill-patients-100573804",false,"NCT06751043","Preoperative Fasting vs. Not Fasting in Critically Ill Patients","FEEDS Trial - Fasting Preprocedurally in Enteral Nutrition: Evaluation of Divergent Approaches in Secure Airway","FEEDS","Inclusion Criteria:\n\n1. 1\\. Age ≥ 18\n2. Current admission to ICU\\*\n3. Secure airway\\*\\* with no plans for its removal prior to procedure\n4. Current non-trophic (\\> 10 mL\u002Fhr) tube (enteral) feeding\\*\\*\\* with no plans to discontinue prior to procedure for reasons other than preoperative fasting\n5. Planned eligible procedure (Examples are listed in Appendix C) with anesthesia care or nursing sedation. Eligible procedures are defined as non-emergent diagnostic or therapeutic interventions that:\n\n   * Do NOT have a well-established practice of preoperative fasting. (For example, bedside placement of a vascular catheter \\[arterial, central venous, peripheral venous\\] by the ICU team is NOT eligible for this trial since it has a widely established practice of no preoperative fasting and is not generally scheduled for a specific time.)\n   * Do NOT require fasting for preoperative gastrointestinal tract preparation\n   * Do NOT require removal\u002Freplacement of the endotracheal or tracheostomy tube\n   * Do NOT require prone or Trendelenburg (head-down) positioning.\n   * Typically require procedural sedation or anesthesia care.\n   * Generally, are scheduled for a specific time (although this time can change, or procedure may be cancelled).\n   * Are performed in the operating room, non-operating room procedural areas, or at the patient's bedside.\n\n     * All ICU types are eligible: surgical, medical, cardiac, neurological, trauma, mixed etc.\n\n       * Secure airway is defined as a cuffed endotracheal tube or a cuffed tracheostomy tube.\n\n         * Patients with all types of feeding tubes are eligible, regardless of tube insertion site (nasal, oral, surgically implanted) and tube tip location (pre- and post-pyloric) †As determined by the enrolling physician-investigator\n\nExclusion Criteria\n\n1. Inability to obtain informed consent\n2. Inability to enroll and randomize \\> 8 hours prior to planned procedure time\n3. Inability to deliver trial interventions\n4. Expected survival \\\u003C 48 hours as determined by the enrolling physician-investigator\n5. Critically ill burn patient\n6. Emergency procedure\n7. a. Gastrointestinal tract procedure that requires fasting based on surgical indications or b. airway\u002Flung procedure that requires removal of endotracheal or tracheostomy tube\n8. Plan for prone or Trendelenburg (head down) positioning during most of the procedure\n9. Major impairment of gastrointestinal motility or major structural disease of the gastrointestinal tract (e.g., severe gastroparesis, bowel obstruction, severe ileus, severely compromised lower esophageal sphincter, active gastrointestinal bleeding)\n10. Plan for postoperative extubation in the procedure area\n11. Prisoner\n12. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test during the current hospitalization, or woman who is breast feeding\n13. Refusal to enroll patient by treating physician\n14. Extracorporeal Membrane Oxygenation (ECMO) at the time of potential enrollment, except patients scheduled for ECMO decannulation as the study procedure and patients expected to be off of ECMO at the time of study procedure.\n15. Chronic mechanical ventilation at pre-admission level of care","ALL","18 Years",{"count":320,"type":321},1072,"ESTIMATED","INTERVENTIONAL",[324],"NA","The goal of this clinical trial is to learn if fasting or not fasting before a procedure has an effect on recovery in those who are critically ill. The main questions it aims to answer for patients on a breathing machine who are receiving tube feeding are:\n\n* Does the risk of lung complications and death differ between those who are not fasting, which may have a higher chance of allowing tube feeding to enter the lungs, and fasting, which temporarily stops nutrition before a procedure?\n* Is there a difference in recovery times, hospital stays, infection rates, need for organ support, safety, and nutrition for those who either fast or do not fast before a procedure?\n* What is the relationship between nutrition and clinical outcomes?\n\nResearchers will compare not fasting and fasting to see if it has an effect on recovery.\n\nParticipants will:\n\n* Be assigned by chance (like a coin toss) to one of two groups. One group (fasting group) will have their tube feeding stopped at least 8 hours before their procedure. The other group (not fasting group) will have their tube feeding stopped right before their procedure.\n* Be monitored via medical record for amount of protein and calories received, and any complications related to fasting\u002Fnot fasting.\n\n  * Data from routine electronic medical records will be reviewed to determine how participants are doing 3 months after their procedure.\n\n'",[327,328,329,9],"Critical Illness","Surgical Procedure, Unspecified","Pulmonary Aspiration",[331,332,333,334,335,336,337,338,339,340,341,342],"pulmonary aspiration","enteral nutrition","tube feeding","preoperative fasting","perioperative medicine","surgery in critically ill","procedures in critically ill","nutrition in critical illness","perioperative safety","preoperative management","preoperative fasting in secure airway","anesthesia in critically ill","2026-06-10",{"date":345,"type":346},"2026-06-12","ACTUAL",{"date":348,"type":346},"2025-04-28",{"date":350,"type":321},"2028-05",{"name":5,"class":6},19]