Ileus Clinical Trial
Official title:
Nasogastric Tube Clamping Trial: Is it Useful? A Proposed Algorithm for Removal.
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.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | September 20, 2020 |
Est. primary completion date | July 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Under the age of 18 - Patient self-removes the NG requiring replacement will be removed from study |
Country | Name | City | State |
---|---|---|---|
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois College of Medicine at Peoria | OSF Healthcare System |
United States,
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.
Ferrer M, Bauer TT, Torres A, Hernández 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. — View Citation
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. — View Citation
Gero D, Gié O, Hübner 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. — View Citation
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. Review. Update in: Cochrane Database Syst Rev. 2015;(5):CD008096. — View Citation
Ibáñez J, Peñafiel A, Raurich JM, Marse P, Jordá 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. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2004 Nov 24. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Pulmonary complications | This outcome looks at any episodes of aspiration pneumonia, pneumonitis, or pneumothorax. | Through study completion, an average of 1 year | |
Secondary | Days until discharge | This outcome will look at the number of days until discharge for all patients in each arm. | Through study completion, an average of 1 year | |
Secondary | Emesis episodes after NG tube removal | This outcome is measured as the number of patients who had an episode of emesis after NG tube removal prior to discharge. | Through study completion, an average of 1 year | |
Secondary | Days until general diet reached | This outcome is measured by looking at how many days it takes from the time of ileus or SBO diagnosis to reach a general diet. | Through study completion, an average of 1 year |
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