RCT: Early Feeding After PEG Placement

Официальное название

A Randomized Controlled Trial to Reduce Periprocedural Fasting in Ventilated Trauma and Surgical Intensive Care Patients

Обзор

Randomized controlled trial to establish evidence on which to base timing of enteral feeding after bedside PEG placement in ventilated Trauma and Surgical ICU patients.

Подробное описание

Trauma and surgical intensive care unit(TSICU) patients supported with mechanical ventilation are at high risk for complications associated with malnutrition (Ambrosino and Clini 2004; Aubier et al. 1985; Hill et al. 1998). To mitigate this risk, therapeutic enteral nutrition(EN) is delivered via nasogastric(NGT), orogastric(OGT), or nasoenteric tube(NET) as soon as possible after admission to the intensive care unit(ICU) or upon restoration of gastrointestinal(GI) continuity. Despite these interventions, TSICU patients often suffer a calorie deficit associated with enteral nutrition interruption(ENI) for procedures or transitions in care(Peev et al. 2015; McClave et al. 2009). These periods of fasting predict quantified caloric deficit associated with complications of malnutrition(Peev et al. 2015; Segaran, Barker, and Hartle 2016). Reduction in ENI duration before and after ICU procedures has yielded decreased caloric deficits within mixed ICU populations(Segaran, Barker, and Hartle 2016).

When the need for EN is prolonged, percutaneous endoscopic gastrostomy tube(PEG) placement is a bedside procedure employed to promote progress toward rehabilitation and disposition out of the ICU. First described in 1980, the technique found its success in replacing the classic open gastrostomy performed through a laparotomy incision under general anesthesia(Gauderer, Ponsky, and Izant 1980). Approximately 100,000-125,000 PEGs are performed annually in the United States(Mendiratta et al. 2012). Despite 40 years of experience and its routine nature in modern critical care settings, there is little evidence on which to base timing of tube feeds after PEG placement in the mechanically ventilated Trauma and Surgical ICU(TSICU) population.

Pre- and post-PEG tube placement fasting practices are highly variable among surgical intensivists. There is no standard of care, despite truncated periods of periprocedural fasting described as safe in previously published retrospective and prospective observational studies. There is no evidence to support prolonged fasting after PEG placement in TSICU patients, thus an opportunity to improve patient outcomes by providing evidence that will encourage earlier feeding and a reduction in calorie deficits.The aim of the study is to encourage a standard of care among surgical intensivists that will help to mitigate the risk of malnutrition in this highly susceptible patient population.

Trauma and Surgical ICU patients undergoing bedside PEG tube placement will be randomized to one of two groups: FAST and noFAST. The FAST group will have post-PEG tube feeds initiated 4 hours after the procedure. The noFAST group will have post-PEG tube feeds initiated \<1 hour after the procedure. Feeds for both are to be initiated at the rate and with the formula the patient was tolerating prior to the procedure.

Вмешательства

• Пищевая добавка noFast: Start tube feeds within 1 hour of procedure
  Earliest possible initiation of tube feeding after bedside PEG tube procedure.

Первичные конечные точки

• Hours fasted [Срок оценки: 24 hours before to 72 hours after the procedure]

Вторичные конечные точки (2)

• Complications [Срок оценки: 0-72 hours after the procedure]
• Calorie deficit [Срок оценки: 24 hours to 72 hours after procedure]

Критерии участия

Критерии включения

• Adult subjects over 18 years of age
• Negative pregnancy test for women participants of child-bearing age
• Mechanically ventilated surgical and trauma patients with clinical indication for PEG tube placement
• Tolerating tube feeds at goal prior to procedure

Критерии исключения

• Patients with aberant gastrointestinal anatomy
• Patients with gastrointestinal motility disorders
• Patients with feeding intolerance prior to PEG tube procedure
• Pregnant women, children, or other vulnerable populations
• Clinical contraindications for PEG tube placement
• PEG performed in setting other than ICU at bedside

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Carilion Roanoke Memorial Hospital — Roanoke

Публикации

• 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 PMID 19398613
• Peev MP, Yeh DD, Quraishi SA, Osler P, Chang Y, Gillis E, Albano CE, Darak S, Velmahos GC. Causes and consequences of interrupted enteral nutrition: a prospective observational study in critically ill surgical patients. JPEN J Parenter Enteral Nutr. 2015 Jan;39(1):21-7. doi: 10.1177/0148607114526887. Epub 2014 Apr 7. PMID 24714361
• Segaran E, Barker I, Hartle A. Optimising enteral nutrition in critically ill patients by reducing fasting times. J Intensive Care Soc. 2016 Feb;17(1):38-43. doi: 10.1177/1751143715599410. Epub 2015 Feb 1. PMID 28979456
• Gauderer MW, Ponsky JL, Izant RJ Jr. Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg. 1980 Dec;15(6):872-5. doi: 10.1016/s0022-3468(80)80296-x. PMID 6780678
• Ali T, Le V, Sharma T, Vega KJ, Srinivasan N, Tierney WM, Rizvi S. Post-PEG feeding time: a web based national survey amongst gastroenterologists. Dig Liver Dis. 2011 Oct;43(10):768-71. doi: 10.1016/j.dld.2011.04.003. Epub 2011 May 31. PMID 21622036
• Stein J, Schulte-Bockholt A, Sabin M, Keymling M. A randomized prospective trial of immediate vs. next-day feeding after percutaneous endoscopic gastrostomy in intensive care patients. Intensive Care Med. 2002 Nov;28(11):1656-60. doi: 10.1007/s00134-002-1473-5. Epub 2002 Sep 6. PMID 12415457
• Gkolfakis P, Arvanitakis M, Despott EJ, Ballarin A, Beyna T, Boeykens K, Elbe P, Gisbertz I, Hoyois A, Mosteanu O, Sanders DS, Schmidt PT, Schneider SM, van Hooft JE. Endoscopic management of enteral tubes in adult patients - Part 2: Peri- and post-procedural management. European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2021 Feb;53(2):178-195. doi: 10.1055/a-1331-8080. Ep PMID 33348410
• Bechtold ML, Matteson ML, Choudhary A, Puli SR, Jiang PP, Roy PK. Early versus delayed feeding after placement of a percutaneous endoscopic gastrostomy: a meta-analysis. Am J Gastroenterol. 2008 Nov;103(11):2919-24. doi: 10.1111/j.1572-0241.2008.02108.x. Epub 2008 Aug 21. PMID 18721239

Идентификаторы

NCT: NCT04110613 · 19-355

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗