Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.
|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Inhaled Carbon Monoxide in Patients With Post-Operative Ileus Following Colon Resection.|
|Study Start Date :||April 2011|
|Primary Completion Date :||September 2013|
|Study Completion Date :||September 2013|
|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
- Duration of post operative ileus (radiologic) [ Time Frame: 1 week ]
- Incidence of pathological post operative ileus [ Time Frame: 1 week ]
- Duration of post operative ileus (clinical) [ Time Frame: 1 week ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050712
|Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 2V7|
|Principal Investigator:||Paul J Belliveau, MD||Queen's University|