Clinical trial NCT01050712: Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.
Official title: Inhaled Carbon Monoxide in Patients With Post-Operative Ileus Following Colon Resection.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ileus
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2010-01-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Sepsis.
* 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.

Primary outcomes:
measure: Duration of post operative ileus (radiologic)
timeFrame: 1 week
measure: Incidence of pathological post operative ileus
timeFrame: 1 week
measure: Duration of post operative ileus (clinical)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Paul J Belliveau, MD
role: PRINCIPAL_INVESTIGATOR
References: