Nasogastric Tube Clamping Trial vs. Immediate Removal
Keywords
Abstract
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.
Dates
| Last Verified: | 08/31/2019 |
| First Submitted: | 06/18/2019 |
| Estimated Enrollment Submitted: | 06/25/2019 |
| First Posted: | 06/27/2019 |
| Last Update Submitted: | 09/25/2019 |
| Last Update Posted: | 09/29/2019 |
| Actual Study Start Date: | 10/14/2019 |
| Estimated Primary Completion Date: | 07/19/2020 |
| Estimated Study Completion Date: | 09/19/2020 |
Condition or disease
Intervention/treatment
Other: Immediate NG tube removal
Other: NG tube clamp trial
Phase
Arm Groups
| 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: 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. |
| 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: 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Necessity of replacement of NG tube [Through study completion, an average of 1 year]
Secondary Outcome Measures
1. Pulmonary complications [Through study completion, an average of 1 year]
2. Days until discharge [Through study completion, an average of 1 year]
3. Emesis episodes after NG tube removal [Through study completion, an average of 1 year]
4. Days until general diet reached [Through study completion, an average of 1 year]
