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Nasogastric Tube Clamping Trial vs. Immediate Removal

Primary Purpose

Small Bowel Obstruction, Ileus

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No clamp trial
Clamp trial
Sponsored by
University of Illinois College of Medicine at Peoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Bowel Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OSF Saint Francis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Immediate NG tube removal

NG tube clamp trial

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pulmonary complications
This outcome looks at any episodes of aspiration pneumonia, pneumonitis, or pneumothorax.
Days until discharge
This outcome will look at the number of days until discharge for all patients in each arm.
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.
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.

Full Information

First Posted
June 19, 2019
Last Updated
September 26, 2019
Sponsor
University of Illinois College of Medicine at Peoria
Collaborators
OSF Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT04001985
Brief Title
Nasogastric Tube Clamping Trial vs. Immediate Removal
Official Title
Nasogastric Tube Clamping Trial: Is it Useful? A Proposed Algorithm for Removal.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Anticipated)
Primary Completion Date
July 20, 2020 (Anticipated)
Study Completion Date
September 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois College of Medicine at Peoria
Collaborators
OSF Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
A high volume of patients are admitted to hospitals yearly for bowel obstruction/ileus complications. Lifetime risk of small bowel obstruction varies from 0.1%-5% if patients have not undergone abdominal surgery, but increases to 30% if the patient underwent a prior abdominal surgery. Ileus is also a common complication in the short term post-operative period. Both of these conditions are initially treated with nasogastric tube decompression if the patient is having emesis. The investigators were unable to find any literature that shows a concrete volume of nasogastric tube output that was deemed the maximum for safe removal. Signs of return of bowel function can indicate it is safe to remove the nasogastric tube. These include flatus, bowel movements, decrease in nasogastric tube output amount, change of nasogastric tube output color from bilious (green) to more gastric (yellow) or salivary (clear/foamy) quality. Some physicians prefer to perform a clamp trial before removal of the nasogastric tube. The duration of the trial and cutoff amount of residual drainage varies among physicians. Regardless of the duration, the nasogastric tube is essentially stenting open the lower esophageal sphincter while it is left in place and not connected to suction. This, theoretically, places the patient at risk for aspiration and subsequent pneumonia. Information in the literature appears divided in regard to aspiration risk. This study hopefully will support the statement that it is safe to remove the nasogastric tube with signs of bowel function, without the need for clamp trials and thus avoiding any possible adverse outcomes associated with the trial. The investigators also anticipate that this study will provide objective guidelines on which patients will continue to improve after nasogastric tube removal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Obstruction, Ileus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate NG tube removal
Arm Type
Active Comparator
Arm Description
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.
Arm Title
NG tube clamp trial
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
No clamp trial
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Clamp trial
Intervention Description
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.
Primary Outcome Measure Information:
Title
Necessity of replacement of NG tube
Description
This measure looks at if the NG tube is replaced in either arm of the study after removal.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Pulmonary complications
Description
This outcome looks at any episodes of aspiration pneumonia, pneumonitis, or pneumothorax.
Time Frame
Through study completion, an average of 1 year
Title
Days until discharge
Description
This outcome will look at the number of days until discharge for all patients in each arm.
Time Frame
Through study completion, an average of 1 year
Title
Emesis episodes after NG tube removal
Description
This outcome is measured as the number of patients who had an episode of emesis after NG tube removal prior to discharge.
Time Frame
Through study completion, an average of 1 year
Title
Days until general diet reached
Description
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.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Alley, MD
Phone
8472756187
Email
ralley@peoriasurgical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Harley Moit, MD
Phone
5732336702
Email
harley_moit@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Alley, MD
Organizational Affiliation
University of Illinois College of Medicine at Peoria
Official's Role
Principal Investigator
Facility Information:
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Alley, MD
Phone
847-275-6187
Email
ralley@peoriasurgical.com
First Name & Middle Initial & Last Name & Degree
Eleni Stroumpi, MD
Phone
309-655
Ext
6988
Email
estrou2@uic.edu
First Name & Middle Initial & Last Name & Degree
Robin Alley, MD
First Name & Middle Initial & Last Name & Degree
Harley Moit, MD
First Name & Middle Initial & Last Name & Degree
Jennifer Rehbein, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
16228094
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.
Results Reference
background
PubMed Identifier
9484734
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. doi: 10.1001/archsurg.133.2.194.
Results Reference
background
PubMed Identifier
1433774
Citation
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.
Results Reference
background
PubMed Identifier
15563632
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. doi: 10.1164/rccm.200408-1069OC. Epub 2004 Nov 24.
Results Reference
background
PubMed Identifier
10383370
Citation
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.
Results Reference
background
PubMed Identifier
20005501
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.
Results Reference
background
PubMed Identifier
27488952
Citation
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.
Results Reference
background
PubMed Identifier
23574854
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.
Results Reference
background
PubMed Identifier
22419328
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.
Results Reference
background
Links:
URL
https://online.epocrates.com/diseases/99323/Small-bowel-obstruction/Epidemiology
Description
Epidemiology

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Nasogastric Tube Clamping Trial vs. Immediate Removal

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