Study of Inhaling Carbon Monoxide to Treat Patients With Intestinal Paralysis After Colon Surgery.

November 15, 2015 updated by: Dr. Paul Belliveau, Queen's University

Inhaled Carbon Monoxide in Patients With Post-Operative Ileus Following Colon Resection.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.
  • No significant abnormalities on history, physical examination or laboratory parameters.

Exclusion Criteria:

  • Exposure to any carbon monoxide source during the 48 hours prior to the study day or occupational exposure to CO.
  • Significant disease or disorder (as explained in Study B).
  • Complete bowel obstruction.
  • Intra-abdominal inflammation (diverticulitis, inflammatory bowel disease, colitis).
  • Retroperitoneal hematomas.
  • Known GI motility disorder.
  • Underlying lung disease such as pneumonia, asthma or COPD.
  • Sepsis.
  • Planned pregnancy, already pregnant or breastfeeding.
  • Electrolyte disturbance (hypokalemia, hypomagnesemia, hyponatremia).
  • Significant opioid and laxative use 4 weeks prior to surgery.
  • Anti-inflammatory use 2 days prior to surgery.
  • Drugs such as antacids, Coumadin, amitriptyline, chlorpromazine.
  • Baseline oxygen saturation <92% on room air.
  • Baseline blood level of COHb >2%.
  • Baseline hemoglobin <90 g/dL.
  • Participation in another clinical trial within 2 months prior to study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of post operative ileus (radiologic)
Time Frame: 1 week
1 week
Incidence of pathological post operative ileus
Time Frame: 1 week
1 week
Duration of post operative ileus (clinical)
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Collaborators

The Physicians' Services Incorporated Foundation

Investigators

  • Principal Investigator: Paul J Belliveau, MD, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

January 14, 2010

First Submitted That Met QC Criteria

January 14, 2010

First Posted (Estimate)

January 15, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POICO-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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