Nasogastric Tube Clamping Trial vs. Immediate Removal

NCT04001985 | Unknown

• 1 other identifier: 1429090-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess the need of clamping nasogastric tubes (NG) before removal. Outcomes of patients admitted requiring nasogastric tube decompression will be compared. Patients with small bowel obstruction (SBO), post-operative ileus, and ileus on admission that require nasogastric tube placement will be included in the study. The patients will be divided into two groups when return of bowel function is suspected based on set criteria for automatic removal of nasogastric tube versus nasogastric tube clamp trial. Specific outcomes will be occurrence of nasogastric tube replacement, number of emeses if any, failure of clamp trial, aspiration pneumonia, and any other unplanned outcome.

Conditions

Small Bowel Obstruction; Ileus

Outcome Measures

Primary Outcomes (1)

• Necessity of replacement of NG tube

  This measure looks at if the NG tube is replaced in either arm of the study after removal.

  Through study completion, an average of 1 year

Secondary Outcomes (4)

• Pulmonary complications

  Through study completion, an average of 1 year

• Days until discharge

  Through study completion, an average of 1 year

• Emesis episodes after NG tube removal

  Through study completion, an average of 1 year

• Days until general diet reached

  Through study completion, an average of 1 year

Study Arms (2)

Immediate NG tube removal

ACTIVE COMPARATOR

Once the NG tube output is less than 500 mL over a 24 hour period with at least two other signs of return of bowel function the NG tube will be removed. Other signs of bowel function include flatus, bowel movement, change of NG tube output from bilious to more clear/frothy character, and hunger.

Other: No clamp trial

NG tube clamp trial

ACTIVE COMPARATOR

Once the NG tube output is less than 500 mL over a 24 hour period with at least two other signs of return of bowel function, a 4 hour clamp trial will be performed. Other signs of bowel function include flatus, bowel movement, change of NG tube output from bilious to more clear/frothy character, and hunger. The NG tube will be taken off of suction and clamped. The NG tube is then reconnected to suction at the end of the four hour clamp trial and removed if less 125 mL drains or kept in place if greater than 125 mL drains. The same initial criteria are used again to determine if a clamp trial will be performed after 24 hours.

Other: Clamp trial

Interventions

No clamp trial OTHER

Once the NG tube output is less than 500 mL over a 24 hour period with at least two other signs of return of bowel function the NG tube will be removed. Other signs of bowel function include flatus, bowel movement, change of NG tube output from bilious to more clear/frothy character, and hunger.

Immediate NG tube removal

Clamp trial OTHER

Once the NG tube output is less than 500 mL over a 24 hour period with at least two other signs of return of bowel function, a 4 hour clamp trial will be performed. Other signs of bowel function include flatus, bowel movement, change of NG tube output from bilious to more clear/frothy character, and hunger. The NG tube will be taken off of suction and clamped. The NG tube is then reconnected to suction at the end of the four hour clamp trial and removed if less 125 mL drains or kept in place if greater than 125 mL drains. The same initial criteria are used again to determine if a clamp trial will be performed after 24 hours.

NG tube clamp trial

Eligibility Criteria

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

You may qualify if:

• Males or females 18 years or older
• Admitted under any of the teaching surgical services for small bowel obstruction or ileus, or develops post-operative ileus
• Patient agreeable to participation in the study

You may not qualify if:

• Under the age of 18
• Patient self-removes the NG requiring replacement will be removed from study

Sponsors & Collaborators

• University of Illinois College of Medicine at Peoria: lead
• OSF Healthcare System: collaborator

Study Sites (1)

OSF Saint Francis Medical Center

Peoria, Illinois, 61603, United States

Location

Related Publications (10)

• Bhimanagouda V. G., Eshwar B. K., Hanumaraddi L. G., Mohammedgouse A. K. Early removal versus conventional removal of nasogastric tube after abdominal surgery: a prospective randomized controlled study. International Surgery Journal 4(1):220-232, 2017.

  BACKGROUND

• Mamun K, Lim J. Role of nasogastric tube in preventing aspiration pneumonia in patients with dysphagia. Singapore Med J. 2005 Nov;46(11):627-31.

  PMID: 16228094 BACKGROUND

• Mitchell CK, Smoger SH, Pfeifer MP, Vogel RL, Pandit MK, Donnelly PJ, Garrison RN, Rothschild MA. Multivariate analysis of factors associated with postoperative pulmonary complications following general elective surgery. Arch Surg. 1998 Feb;133(2):194-8. doi: 10.1001/archsurg.133.2.194.

  PMID: 9484734 BACKGROUND

• Ibanez J, Penafiel A, Raurich JM, Marse P, Jorda R, Mata F. Gastroesophageal reflux in intubated patients receiving enteral nutrition: effect of supine and semirecumbent positions. JPEN J Parenter Enteral Nutr. 1992 Sep-Oct;16(5):419-22. doi: 10.1177/0148607192016005419.

  PMID: 1433774 BACKGROUND

• McAlister FA, Bertsch K, Man J, Bradley J, Jacka M. Incidence of and risk factors for pulmonary complications after nonthoracic surgery. Am J Respir Crit Care Med. 2005 Mar 1;171(5):514-7. doi: 10.1164/rccm.200408-1069OC. Epub 2004 Nov 24.

  PMID: 15563632 BACKGROUND

• Ferrer M, Bauer TT, Torres A, Hernandez C, Piera C. Effect of nasogastric tube size on gastroesophageal reflux and microaspiration in intubated patients. Ann Intern Med. 1999 Jun 15;130(12):991-4. doi: 10.7326/0003-4819-130-12-199906150-00007.

  PMID: 10383370 BACKGROUND

• Izu BS, Monson B, Little AG, Termuhlen PM. Surgical practice: evidence or anecdote. J Surg Educ. 2009 Sep-Oct;66(5):281-4. doi: 10.1016/j.jsurg.2009.07.010.

  PMID: 20005501 BACKGROUND

• Gero D, Gie O, Hubner M, Demartines N, Hahnloser D. Postoperative ileus: in search of an international consensus on definition, diagnosis, and treatment. Langenbecks Arch Surg. 2017 Feb;402(1):149-158. doi: 10.1007/s00423-016-1485-1. Epub 2016 Aug 3.

  PMID: 27488952 BACKGROUND

• Fonseca AL, Schuster KM, Maung AA, Kaplan LJ, Davis KA. Routine nasogastric decompression in small bowel obstruction: is it really necessary? Am Surg. 2013 Apr;79(4):422-8.

  PMID: 23574854 BACKGROUND

• Gomes CA Jr, Lustosa SA, Matos D, Andriolo RB, Waisberg DR, Waisberg J. Percutaneous endoscopic gastrostomy versus nasogastric tube feeding for adults with swallowing disturbances. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD008096. doi: 10.1002/14651858.CD008096.pub3.

  PMID: 22419328 BACKGROUND

Related Links

• Epidemiology

MeSH Terms

Conditions

Ileus

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Robin Alley, MD

  University of Illinois College of Medicine at Peoria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin Alley, MD

CONTACT

8472756187; ralley@peoriasurgical.com

Harley Moit, MD

CONTACT

5732336702; harley_moit@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Robin Alley MD, FACS Assistant Professor of Clinical Surgery, Assistant Program Director

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 28, 2019
• Study Start: October 15, 2019
• Primary Completion: July 20, 2020
• Study Completion: September 20, 2020
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)