Safety Study of Inhaling Carbon Monoxide in Healthy Volunteers

Safety and Tolerability of Inhaled 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 Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: 250 ppm carbon monoxide

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada
      • Kingston General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Event Rate	Before and after carbon monoxide exposure

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: The Physicians' Services Incorporated Foundation
• Investigators: Principal Investigator: Paul Belliveau, MD, Queen's University

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: January 13, 2010
• First Submitted That Met QC Criteria: January 15, 2010
• First Posted (Estimate): January 18, 2010

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 15, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Healthy volunteer
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gasotransmitters; Carbon Monoxide
• Other Study ID Numbers: POICO-A