An interventional study of No clamp trial and Clamp trial in Small Bowel Obstruction and Ileus, sponsored by University of Illinois College of Medicine at Peoria. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by University of Illinois College of Medicine at Peoria · Not applicable, Interventional, and Treatment
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.
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.
160 studies on the registry are indexed under Intestinal Obstruction; 27 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 80 interventional studies indexed under Intestinal Obstruction.
Browse Intestinal Obstruction studies →University of Illinois College of Medicine at Peoria is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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, 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 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.
Necessity of replacement of NG tube
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
Pulmonary complications
This outcome looks at any episodes of aspiration pneumonia, pneumonitis, or pneumothorax.
Time frame: Through study completion, an average of 1 year
Days until discharge
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
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.
Time frame: Through study completion, an average of 1 year
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.
Time frame: Through study completion, an average of 1 year
Plan to share: No
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University of Illinois College of Medicine at Peoria