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Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01050712
Recruitment Status : Terminated (According to retired PI, resident graduated and next resident never carried it to fruition.)
First Posted : January 15, 2010
Last Update Posted : November 17, 2015
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Dr. Paul Belliveau, Queen's University

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.

Condition or disease Intervention/treatment Phase
Ileus Drug: Inhaled Carbon Monoxide Drug: Synthetic Air Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inhaled Carbon Monoxide in Patients With Post-Operative Ileus Following Colon Resection.
Study Start Date : April 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: Carbon Monoxide Drug: Inhaled Carbon Monoxide
Concentration of Carbon Monoxide to be inhaled by patients will be determined in a safety trial performed in healthy volunteers prior to the commencement of this trial. Patients randomized to received inhaled carbon monoxide will receive this concentration by cushioned face mask for one hour prior to colon resection and for one hour after colon resection

Placebo Comparator: Synthetic Air Drug: Synthetic Air
Patients randomized to this intervention will receive this gas via cushioned face mask for one hour prior to colon resection and for one hour after colon resection

Primary Outcome Measures :
  1. Duration of post operative ileus (radiologic) [ Time Frame: 1 week ]
  2. Incidence of pathological post operative ileus [ Time Frame: 1 week ]
  3. Duration of post operative ileus (clinical) [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01050712

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Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
The Physicians' Services Incorporated Foundation
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Principal Investigator: Paul J Belliveau, MD Queen's University
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Responsible Party: Dr. Paul Belliveau, Principal Investigator, Queen's University Identifier: NCT01050712    
Other Study ID Numbers: POICO-B
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Carbon Monoxide
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs