Safety Study of Inhaling Carbon Monoxide in Healthy Volunteers

Healthy Clinical Trial

Official title:

Safety and Tolerability of Inhaled Carbon Monoxide in Healthy Volunteers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01050933
• Other study ID #: POICO-A
• Status: Terminated
• Phase: Phase 1
• First received: January 13, 2010
• Last updated: November 15, 2015
• Start date: September 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

• In good health as per medical history, physical exam, vital signs & ECG.

Exclusion Criteria:

• Exposure to carbon monoxide during the 48 hours prior to the study day.

• Occupational exposure to CO.

• Significant disease that may put the volunteer at risk because of participation in the study or may influence the results of the study or the volunteer's ability to participate in the study.

• Baseline blood level of COHb >2%.

• Patients with underlying lung disease such as asthma or COPD.

• Baseline oxygen saturation <92% on room air.

• Planned pregnancy, already pregnant or breastfeeding.

• Participation in another clinical trial within 2 months prior to study.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 250 ppm carbon monoxide
250 ppm of inhaled carbon monoxide over one hour

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event Rate		Before and after carbon monoxide exposure	Yes