Clinical trial NCT04001985: Nasogastric Tube Clamping Trial vs. Immediate Removal
Official title: Nasogastric Tube Clamping Trial: Is it Useful? A Proposed Algorithm for Removal.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Small Bowel Obstruction
Ileus
Lead sponsor: University of Illinois College of Medicine at Peoria
Sponsor class: OTHER
Collaborators: name: OSF Healthcare System
First posted: 2019-06-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Necessity of replacement of NG tube
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Pulmonary complications
timeFrame: Through study completion, an average of 1 year
measure: Days until discharge
timeFrame: Through study completion, an average of 1 year
measure: Emesis episodes after NG tube removal
timeFrame: Through study completion, an average of 1 year
measure: Days until general diet reached
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
Study officials:
affiliation: University of Illinois College of Medicine at Peoria
name: Robin Alley, MD
role: PRINCIPAL_INVESTIGATOR
References:
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