Safety Study of Inhaling Carbon Monoxide in Healthy Volunteers
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.
This preliminary study will be conducted in ten healthy volunteers to monitor for blood levels and adverse effects that occur at different durations of exposure 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.
We hypothesize that healthy volunteers will be able to tolerate 1 hour doses of 250 ppm of CO with minimal side effects. It is also anticipated that for each dose of CO administered, the blood levels of CO will remain well under poisonous levels. Finally, we anticipate blood levels of CO will return to baseline level within 24 hours following the last dose of CO.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Tolerability of Inhaled Carbon Monoxide in Healthy Volunteers|
- Adverse Event Rate [ Time Frame: Before and after carbon monoxide exposure ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Carbon Monoxide
Healthy volunteers will receive 250 ppm of carbon monoxide by face mask. This dose will be administered for 1 hour with continuous COHb monitoring. At baseline and at each half hour time point, a blood sample will be drawn to be analyzed by the gas chromatograph. After 1 hour, the volunteer will be excused and asked to return in 4 hours and this procedure repeated. At any point, if the COHb level reaches 10%, administration of CO will be terminated.
Drug: 250 ppm carbon monoxide
250 ppm of inhaled carbon monoxide over one hour
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050933
|Kingston General Hospital|
|Kingston, Ontario, Canada|
|Principal Investigator:||Paul Belliveau, MD||Queen's University|