Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.
Primary Purpose
Ileus
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Inhaled Carbon Monoxide
Synthetic Air
Sponsored by
About this trial
This is an interventional treatment trial for Ileus
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.
Sites / Locations
- Kingston General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Carbon Monoxide
Synthetic Air
Arm Description
Outcomes
Primary Outcome Measures
Duration of post operative ileus (radiologic)
Incidence of pathological post operative ileus
Duration of post operative ileus (clinical)
Secondary Outcome Measures
Full Information
NCT ID
NCT01050712
First Posted
January 14, 2010
Last Updated
November 15, 2015
Sponsor
Queen's University
Collaborators
The Physicians' Services Incorporated Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01050712
Brief Title
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
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
According to retired PI, resident graduated and next resident never carried it to fruition.
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
The Physicians' Services Incorporated Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carbon Monoxide
Arm Type
Experimental
Arm Title
Synthetic Air
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Inhaled Carbon Monoxide
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Synthetic Air
Intervention Description
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 Measure Information:
Title
Duration of post operative ileus (radiologic)
Time Frame
1 week
Title
Incidence of pathological post operative ileus
Time Frame
1 week
Title
Duration of post operative ileus (clinical)
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Belliveau, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
12. IPD Sharing Statement
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Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.
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