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出境医 / 临床实验 / Nasogastric Tube Clamping Trial vs. Immediate Removal

Nasogastric Tube Clamping Trial vs. Immediate Removal

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.


Condition or disease Intervention/treatment Phase
Small Bowel Obstruction Ileus Other: No clamp trial Other: Clamp trial Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasogastric Tube Clamping Trial: Is it Useful? A Proposed Algorithm for Removal.
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : September 20, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Immediate NG tube removal
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
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.

Active Comparator: NG tube clamp trial
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
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.

Outcome Measures
Primary Outcome Measures :
  1. Necessity of replacement of NG tube [ Time Frame: Through study completion, an average of 1 year ]
    This measure looks at if the NG tube is replaced in either arm of the study after removal.


Secondary Outcome Measures :
  1. Pulmonary complications [ Time Frame: Through study completion, an average of 1 year ]
    This outcome looks at any episodes of aspiration pneumonia, pneumonitis, or pneumothorax.

  2. Days until discharge [ Time Frame: Through study completion, an average of 1 year ]
    This outcome will look at the number of days until discharge for all patients in each arm.

  3. Emesis episodes after NG tube removal [ Time Frame: Through study completion, an average of 1 year ]
    This outcome is measured as the number of patients who had an episode of emesis after NG tube removal prior to discharge.

  4. Days until general diet reached [ Time Frame: Through study completion, an average of 1 year ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Robin Alley, MD 8472756187 ralley@peoriasurgical.com
Contact: Harley Moit, MD 5732336702 harley_moit@yahoo.com

Locations
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United States, Illinois
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61603
Contact: Robin Alley, MD    847-275-6187    ralley@peoriasurgical.com   
Contact: Eleni Stroumpi, MD    309-655 ext 6988    estrou2@uic.edu   
Principal Investigator: Robin Alley, MD         
Sub-Investigator: Harley Moit, MD         
Sub-Investigator: Jennifer Rehbein, MD         
Sponsors and Collaborators
University of Illinois College of Medicine at Peoria
OSF Healthcare System
Investigators
Layout table for investigator information
Principal Investigator: Robin Alley, MD University of Illinois College of Medicine at Peoria
Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date September 30, 2019
Estimated Study Start Date  ICMJE October 15, 2019
Estimated Primary Completion Date July 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
Necessity of replacement of NG tube [ Time Frame: Through study completion, an average of 1 year ]
This measure looks at if the NG tube is replaced in either arm of the study after removal.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • Pulmonary complications [ Time Frame: Through study completion, an average of 1 year ]
    This outcome looks at any episodes of aspiration pneumonia, pneumonitis, or pneumothorax.
  • Days until discharge [ Time Frame: Through study completion, an average of 1 year ]
    This outcome will look at the number of days until discharge for all patients in each arm.
  • Emesis episodes after NG tube removal [ Time Frame: Through study completion, an average of 1 year ]
    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 [ Time Frame: Through study completion, an average of 1 year ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nasogastric Tube Clamping Trial vs. Immediate Removal
Official Title  ICMJE Nasogastric Tube Clamping Trial: Is it Useful? A Proposed Algorithm for Removal.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Small Bowel Obstruction
  • Ileus
Intervention  ICMJE
  • Other: No clamp trial
    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: Clamp trial
    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.
Study Arms  ICMJE
  • Active Comparator: Immediate NG tube removal
    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: Other: No clamp trial
  • Active Comparator: NG tube clamp trial
    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: Other: Clamp trial
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 20, 2020
Estimated Primary Completion Date July 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Robin Alley, MD 8472756187 ralley@peoriasurgical.com
Contact: Harley Moit, MD 5732336702 harley_moit@yahoo.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04001985
Other Study ID Numbers  ICMJE 1429090-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robin Alley, University of Illinois College of Medicine at Peoria
Study Sponsor  ICMJE University of Illinois College of Medicine at Peoria
Collaborators  ICMJE OSF Healthcare System
Investigators  ICMJE
Principal Investigator: Robin Alley, MD University of Illinois College of Medicine at Peoria
PRS Account University of Illinois College of Medicine at Peoria
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP