Inhaled Carbon Monoxide in Patients With Post-Operative Ileus Following Colon Resection.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Duration of post operative ileus (clinical)
研究概览
简要总结
Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care problem. It normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. The objective of this study is to determine if inhaling very low doses of carbon monoxide (CO) before and after colon surgery will shorten the duration of normal POI and/or prevent the development of POI complications in patients undergoing colon surgery.
A preliminary study will be conducted in six healthy volunteers to monitor for blood levels and adverse effects that occur at 3 different doses of inhaled CO to establish a safe dose for patients in the main trial. For the main trial, patients requiring surgery to their colon will be assigned randomly to receive one hour treatments of either CO or oxygen by face mask before and after their operation. Length of normal POI and occurrence of POI complications will be compared between the two groups. Side effects that occur from inhaling CO or oxygen will also be recorded.
We hypothesize that inhaling CO before and after colon surgery will shorten the length of normal POI and decrease the occurrence of POI complications with minimal side effects.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, age > 18 years.
- •Women must be using acceptable contraceptives, post-menopausal or surgically sterile.
- •No prior smoking history.
- •BMI between 16 and 30 inclusive.
- •No significant abnormalities on history, physical examination or laboratory parameters.
排除标准
- •Exposure to any carbon monoxide source during the 48 hours prior to the study day or occupational exposure to CO.
- •Significant disease or disorder (as explained in Study B).
- •Complete bowel obstruction.
- •Intra-abdominal inflammation (diverticulitis, inflammatory bowel disease, colitis).
- •Retroperitoneal hematomas.
- •Known GI motility disorder.
- •Underlying lung disease such as pneumonia, asthma or COPD.
- •Planned pregnancy, already pregnant or breastfeeding.
- •Electrolyte disturbance (hypokalemia, hypomagnesemia, hyponatremia).
- •Significant opioid and laxative use 4 weeks prior to surgery.
- •Anti-inflammatory use 2 days prior to surgery.
- •Drugs such as antacids, Coumadin, amitriptyline, chlorpromazine.
- •Baseline oxygen saturation <92% on room air.
- •Baseline blood level of COHb >2%.
- •Baseline hemoglobin <90 g/dL.
- •Participation in another clinical trial within 2 months prior to study.
研究组 & 干预措施
Carbon Monoxide
干预措施: Inhaled Carbon Monoxide (Drug)
Synthetic Air
干预措施: Synthetic Air (Drug)
结局指标
主要结局
Duration of post operative ileus (clinical)
时间窗: 1 week
Duration of post operative ileus (radiologic)
时间窗: 1 week
Incidence of pathological post operative ileus
时间窗: 1 week
次要结局
未报告次要终点
研究者
Dr. Paul Belliveau
Principal Investigator
Queen's University