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

Sponsor

Queen's University (Other)

Overall Status

Terminated

CT.gov ID

NCT01050712

Collaborator

The Physicians' Services Incorporated Foundation (Other)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Ileus	Drug: Inhaled Carbon Monoxide Drug: Synthetic Air	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Duration of post operative ileus (radiologic) [1 week]
Incidence of pathological post operative ileus [1 week]
Duration of post operative ileus (clinical) [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kingston General Hospital	Kingston	Ontario	Canada	K7L 2V7

Sponsors and Collaborators

Queen's University
The Physicians' Services Incorporated Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Paul Belliveau, Principal Investigator, Queen's University

ClinicalTrials.gov Identifier:

NCT01050712

Other Study ID Numbers:

POICO-B

First Posted:

Jan 15, 2010

Last Update Posted:

Nov 17, 2015

Last Verified:

Nov 1, 2015

Additional relevant MeSH terms:

Ileus

Carbon Monoxide

Study Results

No Results Posted as of Nov 17, 2015