Nasogastric Tube Clamping Trial: Is it Useful? A Proposed Algorithm for Removal.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Necessity of replacement of NG tube
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Under the age of 18
- •Patient self-removes the NG requiring replacement will be removed from study
研究组 & 干预措施
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.
干预措施: No clamp trial (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.
干预措施: Clamp trial (Other)
结局指标
主要结局
Necessity of replacement of NG tube
时间窗: 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.
次要结局
- Pulmonary complications(Through study completion, an average of 1 year)
- Days until discharge(Through study completion, an average of 1 year)
- Emesis episodes after NG tube removal(Through study completion, an average of 1 year)
- Days until general diet reached(Through study completion, an average of 1 year)
研究者
Robin Alley
Robin Alley MD, FACS Assistant Professor of Clinical Surgery, Assistant Program Director
University of Illinois College of Medicine at Peoria