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Safety Study of Inhaling Carbon Monoxide in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Queen's University
ClinicalTrials.gov Identifier:
NCT01050933
First received: January 13, 2010
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: 250 ppm carbon monoxide
 Phase 1

Study Type: Interventional
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

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Adverse Event Rate [ Time Frame: Before and after carbon monoxide exposure ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050933

Locations
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada
Sponsors and Collaborators
Queen's University
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Paul Belliveau, MD Queen's University
  More Information

No publications provided

Responsible Party: Queen's University
ClinicalTrials.gov Identifier: NCT01050933     History of Changes
Other Study ID Numbers: POICO-A
Study First Received: January 13, 2010
Last Updated: July 31, 2012
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Healthy volunteer

Additional relevant MeSH terms:
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013