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Surgical patients fed up until the point of surgery will have safe delivery of more calories compared to a group whose feeding is held at midnight prior to surgery.
Nutrition is essential for healing and recovery from illness. Tube feeds are the standard care for patients with prolonged stays in the intensive care unit (ICU) who cannot eat food on their own. Tube feeding means that a tube has been placed in a patient's stomach or small intestine to provide nutrition.
When a patient is scheduled for an elective surgery, he/she usually has nothing to eat after midnight prior to the operation. A fasting period before surgery is done to avoid possible side effects during the placement of a breathing tube. Having an empty stomach is thought to decrease the chances of vomiting or aspiration while a breathing tube is placed. (Aspiration occurs when a substance, such as food provided by a tube feed, enters the airway.) However, some patients already have a breathing tube in place. The investigators do not know which is better for patients who already have a breathing tube in place: continuing feedings up until surgery or stopping them the night before.
The investigators hypothesize intubated surgical patients randomized to a protocol of feeding up until the point of surgery will have the safe delivery of more calories as compared to a group whose feeding is held at midnight prior to surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Tube feeds are held night prior to elective surgery (standard of care) | |
| Continuous Feeding | Experimental | Tube feeds are continued up until surgery. Subjects with a nasogastric tube will have their stomach contents emptied prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Tube Feedings | Dietary Supplement | Tube feeds continued up until elective surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total calories delivered | The total number of calories subject consume while receiving tube feeding. | Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory values | Laboratory values of interest include: CBC, liver function tests, basic metabolic panel, magnesium, phosphate, alubmin, prealubumin, c-reactive protein, and arterial blood gas. | Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laszlo Kiraly, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11566654 | Background | Braunschweig CL, Levy P, Sheean PM, Wang X. Enteral compared with parenteral nutrition: a meta-analysis. Am J Clin Nutr. 2001 Oct;74(4):534-42. doi: 10.1093/ajcn/74.4.534. | |
| 1616387 | Background | Kudsk KA, Croce MA, Fabian TC, Minard G, Tolley EA, Poret HA, Kuhl MR, Brown RO. Enteral versus parenteral feeding. Effects on septic morbidity after blunt and penetrating abdominal trauma. Ann Surg. 1992 May;215(5):503-11; discussion 511-3. doi: 10.1097/00000658-199205000-00013. |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Subjects are randomized to remain NPO at midnight prior to surgery or to continue to receive tube feeding up until surgery time.
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| Weight change |
The change of weight during hospital admission. |
| Daily for length of stay (LOS). LOS defined as time from admission to discharge. LOS estimated to average three (3) weeks per participant. |
| number of infections and aspiration events | Number of infections or aspiration events during hospitalization | From date of randomization until the date of documented complication. Subjects will be followed until discharge in case of multiple complications. Date of discharge is estimated to be three (3) weeks post-admission on average. |
| 9448611 | Background | Kalfarentzos F, Kehagias J, Mead N, Kokkinis K, Gogos CA. Enteral nutrition is superior to parenteral nutrition in severe acute pancreatitis: results of a randomized prospective trial. Br J Surg. 1997 Dec;84(12):1665-9. |
| 19398613 | Background | McClave SA, Martindale RG, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G; A.S.P.E.N. Board of Directors; American College of Critical Care Medicine; Society of Critical Care Medicine. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):277-316. doi: 10.1177/0148607109335234. No abstract available. |
| 8195265 | Background | Jenkins ME, Gottschlich MM, Warden GD. Enteral feeding during operative procedures in thermal injuries. J Burn Care Rehabil. 1994 Mar-Apr;15(2):199-205. doi: 10.1097/00004630-199403000-00019. |
| 19251911 | Background | Pousman RM, Pepper C, Pandharipande P, Ayers GD, Mills B, Diaz J, Collier B, Miller R, Jensen G. Feasibility of implementing a reduced fasting protocol for critically ill trauma patients undergoing operative and nonoperative procedures. JPEN J Parenter Enteral Nutr. 2009 Mar-Apr;33(2):176-80. doi: 10.1177/0148607108327527. |