RCT: Early Feeding After PEG Placement

NCT04110613 | Recruiting

• 1 other identifier: 19-355
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness; Malnutrition; Gastrostomy; Procedural Sequelae; Trauma; Surgery; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• Hours fasted

  Number of hours patients are not receiving prescribed caloric intake

  24 hours before to 72 hours after the procedure

Secondary Outcomes (2)

• Complications

  0-72 hours after the procedure

• Calorie deficit

  24 hours to 72 hours after procedure

Study Arms (2)

noFast: Start tube feeds within 1 hour of procedure

ACTIVE COMPARATOR

The noFAST group will have post-PEG tube feeds initiated \<1 hour after the procedure. Feeds are to be initiated at the rate and with the formula the patient was tolerating prior to the procedure.

Dietary Supplement: noFast: Start tube feeds within 1 hour of procedure

FAST: Start tube feeds 4 hours after procedure

NO INTERVENTION

The FAST group will have post-PEG tube feeds initiated 4 hours after the procedure. Feeds are to be initiated at the rate and with the formula the patient was tolerating prior to the procedure.

Interventions

noFast: Start tube feeds within 1 hour of procedure DIETARY_SUPPLEMENT

Earliest possible initiation of tube feeding after bedside PEG tube procedure.

noFast: Start tube feeds within 1 hour of procedure

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

RECRUITING

Related Publications (20)

• 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.

  PMID: 19398613 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. Epub 2020 Dec 21.

  PMID: 33348410 BACKGROUND

• 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 BACKGROUND

• Cobell WJ, Hinds AM, Nayani R, Akbar S, Lim RG, Theivanayagam S, Matteson-Kome ML, Choudhary A, Puli SR, Bechtold ML. Feeding after percutaneous endoscopic gastrostomy: experience of early versus delayed feeding. South Med J. 2014 May;107(5):308-11. doi: 10.1097/SMJ.0000000000000104.

  PMID: 24937731 BACKGROUND

• Szary NM, Arif M, Matteson ML, Choudhary A, Puli SR, Bechtold ML. Enteral feeding within three hours after percutaneous endoscopic gastrostomy placement: a meta-analysis. J Clin Gastroenterol. 2011 Apr;45(4):e34-8. doi: 10.1097/MCG.0b013e3181eeb732.

  PMID: 20733512 BACKGROUND

• Vyawahare MA, Shirodkar M, Gharat A, Patil P, Mehta S, Mohandas KM. A comparative observational study of early versus delayed feeding after percutaneous endoscopic gastrostomy. Indian J Gastroenterol. 2013 Nov;32(6):366-8. doi: 10.1007/s12664-013-0348-8. Epub 2013 Aug 17.

  PMID: 23949988 BACKGROUND

• Dubagunta S, Still CD, Kumar A, Makhdoom Z, Inverso NA, Bross RJ, Komar MJ, Mulhisen L, Rogers JZ, Whitmire S, Whilden B. Early initiation of enteral feeding after percutaneous endoscopic gastrostomy tube placement. Nutr Clin Pract. 2002 Apr;17(2):123-5. doi: 10.1177/0115426502017002123.

  PMID: 16214975 BACKGROUND

• Schneider AS, Schettler A, Markowski A, Luettig B, Kaufmann B, Klamt S, Lenzen H, Momma M, Seipt C, Lankisch T, Negm AA; *Conference presentation: 36th ESPEN Congress in Leipzig, Germany on August 31st - September 3rd, 2013. Complication and mortality rate after percutaneous endoscopic gastrostomy are low and indication-dependent. Scand J Gastroenterol. 2014 Jul;49(7):891-8. doi: 10.3109/00365521.2014.916343. Epub 2014 Jun 4.

  PMID: 24896841 BACKGROUND

• Boullata JI, Carrera AL, Harvey L, Escuro AA, Hudson L, Mays A, McGinnis C, Wessel JJ, Bajpai S, Beebe ML, Kinn TJ, Klang MG, Lord L, Martin K, Pompeii-Wolfe C, Sullivan J, Wood A, Malone A, Guenter P; ASPEN Safe Practices for Enteral Nutrition Therapy Task Force, American Society for Parenteral and Enteral Nutrition. ASPEN Safe Practices for Enteral Nutrition Therapy [Formula: see text]. JPEN J Parenter Enteral Nutr. 2017 Jan;41(1):15-103. doi: 10.1177/0148607116673053. Epub 2016 Nov 5.

  PMID: 27815525 BACKGROUND

• Blaser AR, Starkopf J, Kirsimagi U, Deane AM. Definition, prevalence, and outcome of feeding intolerance in intensive care: a systematic review and meta-analysis. Acta Anaesthesiol Scand. 2014 Sep;58(8):914-22. doi: 10.1111/aas.12302. Epub 2014 Mar 11.

  PMID: 24611520 BACKGROUND

• ASGE Training Committee 2013-2014; Enestvedt BK, Jorgensen J, Sedlack RE, Coyle WJ, Obstein KL, Al-Haddad MA, Christie JA, Davila RE, Mullady DK, Kubiliun N, Kwon RS, Law R, Qureshi WA. Endoscopic approaches to enteral feeding and nutrition core curriculum. Gastrointest Endosc. 2014 Jul;80(1):34-41. doi: 10.1016/j.gie.2014.02.011. Epub 2014 Apr 26. No abstract available.

  PMID: 24773773 BACKGROUND

• Ambrosino N, Clini E. Long-term mechanical ventilation and nutrition. Respir Med. 2004 May;98(5):413-20. doi: 10.1016/j.rmed.2003.11.008.

  PMID: 15139570 BACKGROUND

• Aubier M, Murciano D, Lecocguic Y, Viires N, Jacquens Y, Squara P, Pariente R. Effect of hypophosphatemia on diaphragmatic contractility in patients with acute respiratory failure. N Engl J Med. 1985 Aug 15;313(7):420-4. doi: 10.1056/NEJM198508153130705.

  PMID: 3860734 BACKGROUND

• Hill AT, Edenborough FP, Cayton RM, Stableforth DE. Long-term nasal intermittent positive pressure ventilation in patients with cystic fibrosis and hypercapnic respiratory failure (1991-1996). Respir Med. 1998 Mar;92(3):523-6. doi: 10.1016/s0954-6111(98)90302-x.

  PMID: 9692116 BACKGROUND

• Sivasothy P, Smith IE, Shneerson JM. Mask intermittent positive pressure ventilation in chronic hypercapnic respiratory failure due to chronic obstructive pulmonary disease. Eur Respir J. 1998 Jan;11(1):34-40. doi: 10.1183/09031936.98.11010034.

  PMID: 9543267 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Malnutrition; Wounds and Injuries

Interventions

Methods

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Katie L Bower, MD

  Carilion Clinic, Virginia Tech Carilion School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie L. Bower, MD

CONTACT

540-981-7434; klbower@vt.edu

Jordan Darden, PhD

CONTACT

540-529-7792; jadarden@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Once scheduled for the bedside PEG procedure, patients will be randomized to either the experimental NoFAST group or the control FAST group.

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: October 1, 2019
• Study Start: September 19, 2019
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)